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Job Description
Job title : GQC Infrastructure & Lab Supplies Operations
Director
Department : Global Quality Control
Line Manager Job Title : Global Quality Control Vice President
Time period : January 2010 – December 2014
Job purpose
Lead, organize and develop the GQC Infrastructure & Lab Supplies Operations
department in terms of
- Lab Support Operations
- Infrastructure Management operations
- Validations Operations
- Samples Management
in order to :
- support release of commercial and non-commercial vaccine products, raw
materials ;
- secure GQC – Belgian sites and R&D Global Clinical Read Out BU and
departmental objectives & projects by providing laboratories, equipment’s,
media, glassware & materials with the ‘state of the art’ and validated
expected level and the optimal support needed, by promoting Information
Management Systems developments and lab automation initiatives ;
- drive department supportive workforce and mindset to enhance lab
workforce focus on laboratory priorities ;
- improve & promote capacity management, productivity, added value and
cost control ;
- harmonize of QC standard & practices between sites in terms of equipment
and data reduction softwares (calculation sheets included) validations,
sample management ;
with the highest quality in accordance with cGMP's, EHS requirements and the
defined standard lead-times.
Key Responsibilities
 Lead the Lab Support Operations department (Material & Media
preparation / Warehouse & Supply) to support GQC Laboratories (Biology,
Biophysico-chemistry and GQC New Product Analytical Strategy &
Support), VDD.
 Lead the Infrastructure Management operations (Maintenance / Calibration
& Measurement ) to ensure that QC infrastructure remain state of the art
in term of technology, cGMP and legal constraints.
 Lead the Validation Operations full process for GQC to ensure that
automated, analytical & laboratory systems remains state of the art in
terms of technology , cGMP and legal constraints. Support VDD
organization for commissioning of new equipments.
 Lead the GQC IT request process with The Quality IT Partner: propose,
consolidate and follow the GQC IT 5Y Vision plan (strategic projects).
Consolidate and prioritize lifecycle and new IT requests. Facilitate final
decision by the GQC Leadership Team.
 Lead the management of overall QC samples (reagents, standards,
stability) inventory, logistics and global supply to GSK Vaccines sites, as
well as to National Control Laboratories (NCL’s).
 Promote harmonization of QC standard & practices of equipment and data
reduction softwares (calculation sheets included) validations, sample
management within Global and Belgium QC (650 persons), GSK vaccine
sites or CMO (more than 15 sites-350 persons).
 Ensure QC representation during inspection/ audits
 Provide support to different departments (GQC, GIO MPUs, VDD, etc) for
existing and new products development, validations as well as
investigations.
 Lead GQC Infra & LabSO resources (people, equipment, and budget).
Select, train, supervise and evaluate the direct reports and their related
staff. Foster motivation and development of the whole staff through
adequate performance management, feedback, coaching, training, and
communication.
 Lead change initiatives involving processes, technologies and people which
contribute to the overall effectiveness of the department. Lead the
implementation of Operational Excellence projects.
 Budget : prepare, control and defend budgets for the department.
Breadth/ Scope of Accountability
Number of Direct Report 6
Number of Indirect Reports +/- 150 fees included
Assets Managed Accountability 400 Mio €
Operating Budget Accountability 10,000 k€ (Managerial expenses)
Complexity:
Degree of change & uncertainty
 Vaccines are associated with a significant level of uncertainties in sales
volumes, capacity adaptation to commercial activity is therefore uncertain.
Development products require by essence numerous complex, evolving
and challenging technologies. Internationalization of Industrialization
activities also increases the complexity. This requires a high level of rigor,
together with an open mind and flexible approach of problem-solving, as
well as multidisciplinary scientific-based rationales and communication
capabilities
 Non-commercial activity is by nature variable and depends on products
and technology development, originating from inside the QC organization,
or from other department (MCoE, R&D, and Industrialisation). Continuous
changes associated to evolving requirements and standards, new products
and technologies are adding a significant level of complexity.
Level of influencing required
 Jobs responsibility deals with Quality decisions, Vaccines Supply Chain
Management, QC and R&D development activities, laboratory
infrastructures capacities. These responsibilities expose the job holder to
GSK Biologicals, GSK corporate, national and international organization
and authorities. Through this position, the job holder influence business
decisions with short, mid and long term effect. This requires strong
capacity to convince and inspire, based on facts, data and trust.
 The incumbent must operate cross-functionally and be able to lead in a
matrix organization. The incumbent must be able to build and sustain
personal relationships with peers and subordinates to succeed. The
incumbent must master roles as leader, facilitator, advisor, consultant,
negotiator and trainer. The incumbent must operate also as expert and
leader in analytical processes outside manufacturing operations, mainly
with the R&D activities but also with Regulatory Affairs department.
 The incumbent must operate within a complex organization involving
numerous scientific disciplines. He must maintain right balance between
sense of urgency (day-to-day problem solving) and long term
thinking/innovation skills.
Global Network
 Scope of interactions includes all QC and R&D GCRO internal customers
(+/- 700), and strong interfacing with Global and Site Technical Services,
Procurement, QA, IT, HR, MCoE, Warehouses and EHS departments.
 Job requires executive networking with other Bio sites QC organization and
master facilities e.g. for capacity and business continuity management.
Human relations
Able to build and maintain good personnel relationships within workers, able to
motivate people and bring them to excellence. Lead of people with high expert
background. A deep sense of collaboration and a transversal attitude are
required to cope with the alignment of objectives with other technical or
operation groups (in Belgium and with international sites).
Specialized Knowledge:
 Scientific grade: University Degree + Master of Business Administration
 Min. 10-15 years experience of technical & laboratory operational expertise in
a quality control environment
 Broad view of GSK Biologicals products and organization, production
processes and vaccine technologies.
 Knowledge of the cGMP in the frame of the GSK Biologicals business
 Executive capability to manage and lead people, Strong leadership of highly
qualified technical & scientific experts (PhD, engineers) as an operational
team in a demanding and challenging competitive environment. Able to
motivate people of different disciplines and qualifications.
 Executive capability to manage a large organization with a lot of people and
facilities.
 Ability to lead in a global organization.
 Good economical approach, capability to manage a substantial budget.
 Able to take a broad and long-term perspective, able to make high level
decisions.
 Good networking (internal as well as external) and influencing skills.
 Proven communication, influence and negotiation skills.
Good decision making, problem solving skills
Knowledge/ Education / Previous
Experience Required*
A. Educational Background
List any academic or practical education that
must be obtained to be qualified to perform
this role.
1. Minimum Level of
Education*
5 Years Scientific university degree.
Area of Specialisation* Biology, Chemistry, Agronomy,…
Why is this Level of
Education Required?
To integrate supply chain and capacity management in a
scientific environment (Quality Control – 650 FTE) with basics
in financial mastery and in a 3 to 10 years perspective.
2. Preferred Level of
Education
Agronomy or Bio Engineer + MBA or equivalent
Area of Specialisation Generalist + Supply Chain Management
Why is this Level of
Education Preferred?
To integrate supply chain and capacity management in
a scientific environment (Quality Control – 650 FTE)
with basics in financial mastery and in a 3 to 10 years
perspective.
B. Job-Related Experience
Describe what experience this position will require the job holder to have obtained in
past roles within or outside of GSK that would demonstrate a level of proficiency in
the stated role.
Minimum Level of Job-
Related Experience
required
10 Years experience in Pharmaceutical Manufacturing or
Quality Control Environment including transverse project
management in domains such as continuous improvement,
lean culture, infrastructure or lab automation.
Why is this Level of
Experience Required?
To integrate supply chain and capacity management in
a scientific environment (Quality Control – 650 FTE)
with basics in financial mastery and in a 3 to 10 years
perspective.
C. Other Job-Related Skills/Background
List any licenses, certificates, registrations, or any relevant job skill or abilities not
covered in Educational Background or Job-Related Experience sections above that
are required for the job.
cGMP aligned.
Expected behaviors : Customer focus / Shopfloor oriented / Proactive / Result oriented
LEADERship behaviors : Live GSK Valuies / Enage / Align / Develop / Execute / Renew
Good communication skills (leading managers, white & blue collars)
Act as generalist by leading experts.

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JD GQC Infra & LabSO - Director - 2010 to 2014

  • 1. Job Description Job title : GQC Infrastructure & Lab Supplies Operations Director Department : Global Quality Control Line Manager Job Title : Global Quality Control Vice President Time period : January 2010 – December 2014 Job purpose Lead, organize and develop the GQC Infrastructure & Lab Supplies Operations department in terms of - Lab Support Operations - Infrastructure Management operations - Validations Operations - Samples Management in order to : - support release of commercial and non-commercial vaccine products, raw materials ; - secure GQC – Belgian sites and R&D Global Clinical Read Out BU and departmental objectives & projects by providing laboratories, equipment’s, media, glassware & materials with the ‘state of the art’ and validated expected level and the optimal support needed, by promoting Information Management Systems developments and lab automation initiatives ; - drive department supportive workforce and mindset to enhance lab workforce focus on laboratory priorities ; - improve & promote capacity management, productivity, added value and cost control ; - harmonize of QC standard & practices between sites in terms of equipment and data reduction softwares (calculation sheets included) validations, sample management ; with the highest quality in accordance with cGMP's, EHS requirements and the defined standard lead-times. Key Responsibilities  Lead the Lab Support Operations department (Material & Media preparation / Warehouse & Supply) to support GQC Laboratories (Biology, Biophysico-chemistry and GQC New Product Analytical Strategy & Support), VDD.  Lead the Infrastructure Management operations (Maintenance / Calibration & Measurement ) to ensure that QC infrastructure remain state of the art in term of technology, cGMP and legal constraints.  Lead the Validation Operations full process for GQC to ensure that automated, analytical & laboratory systems remains state of the art in terms of technology , cGMP and legal constraints. Support VDD organization for commissioning of new equipments.  Lead the GQC IT request process with The Quality IT Partner: propose,
  • 2. consolidate and follow the GQC IT 5Y Vision plan (strategic projects). Consolidate and prioritize lifecycle and new IT requests. Facilitate final decision by the GQC Leadership Team.  Lead the management of overall QC samples (reagents, standards, stability) inventory, logistics and global supply to GSK Vaccines sites, as well as to National Control Laboratories (NCL’s).  Promote harmonization of QC standard & practices of equipment and data reduction softwares (calculation sheets included) validations, sample management within Global and Belgium QC (650 persons), GSK vaccine sites or CMO (more than 15 sites-350 persons).  Ensure QC representation during inspection/ audits  Provide support to different departments (GQC, GIO MPUs, VDD, etc) for existing and new products development, validations as well as investigations.  Lead GQC Infra & LabSO resources (people, equipment, and budget). Select, train, supervise and evaluate the direct reports and their related staff. Foster motivation and development of the whole staff through adequate performance management, feedback, coaching, training, and communication.  Lead change initiatives involving processes, technologies and people which contribute to the overall effectiveness of the department. Lead the implementation of Operational Excellence projects.  Budget : prepare, control and defend budgets for the department. Breadth/ Scope of Accountability Number of Direct Report 6 Number of Indirect Reports +/- 150 fees included Assets Managed Accountability 400 Mio € Operating Budget Accountability 10,000 k€ (Managerial expenses) Complexity: Degree of change & uncertainty  Vaccines are associated with a significant level of uncertainties in sales volumes, capacity adaptation to commercial activity is therefore uncertain. Development products require by essence numerous complex, evolving and challenging technologies. Internationalization of Industrialization activities also increases the complexity. This requires a high level of rigor, together with an open mind and flexible approach of problem-solving, as well as multidisciplinary scientific-based rationales and communication capabilities  Non-commercial activity is by nature variable and depends on products and technology development, originating from inside the QC organization, or from other department (MCoE, R&D, and Industrialisation). Continuous changes associated to evolving requirements and standards, new products and technologies are adding a significant level of complexity. Level of influencing required  Jobs responsibility deals with Quality decisions, Vaccines Supply Chain Management, QC and R&D development activities, laboratory infrastructures capacities. These responsibilities expose the job holder to
  • 3. GSK Biologicals, GSK corporate, national and international organization and authorities. Through this position, the job holder influence business decisions with short, mid and long term effect. This requires strong capacity to convince and inspire, based on facts, data and trust.  The incumbent must operate cross-functionally and be able to lead in a matrix organization. The incumbent must be able to build and sustain personal relationships with peers and subordinates to succeed. The incumbent must master roles as leader, facilitator, advisor, consultant, negotiator and trainer. The incumbent must operate also as expert and leader in analytical processes outside manufacturing operations, mainly with the R&D activities but also with Regulatory Affairs department.  The incumbent must operate within a complex organization involving numerous scientific disciplines. He must maintain right balance between sense of urgency (day-to-day problem solving) and long term thinking/innovation skills. Global Network  Scope of interactions includes all QC and R&D GCRO internal customers (+/- 700), and strong interfacing with Global and Site Technical Services, Procurement, QA, IT, HR, MCoE, Warehouses and EHS departments.  Job requires executive networking with other Bio sites QC organization and master facilities e.g. for capacity and business continuity management. Human relations Able to build and maintain good personnel relationships within workers, able to motivate people and bring them to excellence. Lead of people with high expert background. A deep sense of collaboration and a transversal attitude are required to cope with the alignment of objectives with other technical or operation groups (in Belgium and with international sites). Specialized Knowledge:  Scientific grade: University Degree + Master of Business Administration  Min. 10-15 years experience of technical & laboratory operational expertise in a quality control environment  Broad view of GSK Biologicals products and organization, production processes and vaccine technologies.  Knowledge of the cGMP in the frame of the GSK Biologicals business  Executive capability to manage and lead people, Strong leadership of highly qualified technical & scientific experts (PhD, engineers) as an operational team in a demanding and challenging competitive environment. Able to motivate people of different disciplines and qualifications.  Executive capability to manage a large organization with a lot of people and facilities.  Ability to lead in a global organization.  Good economical approach, capability to manage a substantial budget.  Able to take a broad and long-term perspective, able to make high level decisions.  Good networking (internal as well as external) and influencing skills.  Proven communication, influence and negotiation skills.
  • 4. Good decision making, problem solving skills
  • 5. Knowledge/ Education / Previous Experience Required* A. Educational Background List any academic or practical education that must be obtained to be qualified to perform this role. 1. Minimum Level of Education* 5 Years Scientific university degree. Area of Specialisation* Biology, Chemistry, Agronomy,… Why is this Level of Education Required? To integrate supply chain and capacity management in a scientific environment (Quality Control – 650 FTE) with basics in financial mastery and in a 3 to 10 years perspective. 2. Preferred Level of Education Agronomy or Bio Engineer + MBA or equivalent Area of Specialisation Generalist + Supply Chain Management Why is this Level of Education Preferred? To integrate supply chain and capacity management in a scientific environment (Quality Control – 650 FTE) with basics in financial mastery and in a 3 to 10 years perspective. B. Job-Related Experience Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role. Minimum Level of Job- Related Experience required 10 Years experience in Pharmaceutical Manufacturing or Quality Control Environment including transverse project management in domains such as continuous improvement, lean culture, infrastructure or lab automation. Why is this Level of Experience Required? To integrate supply chain and capacity management in a scientific environment (Quality Control – 650 FTE) with basics in financial mastery and in a 3 to 10 years perspective. C. Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. cGMP aligned. Expected behaviors : Customer focus / Shopfloor oriented / Proactive / Result oriented LEADERship behaviors : Live GSK Valuies / Enage / Align / Develop / Execute / Renew Good communication skills (leading managers, white & blue collars) Act as generalist by leading experts.