1. Job Description
Job title : GQC Technical Services Senior Manager
Department : Quality Control
Line Manager Job Title : Quality Control Director
Time period : January 2006 – December 2010
Job purpose
Lead, organize and develop the QC Technological Support department in
terms of
- Business Process Management
- Logistics Operations
- Demand, Planning & Capacity Management
- Infrastructure & Analytical Systems Management
in order to :
- release commercial and non-commercial vaccine products
- secure QC Technology and R&D Global Clinical Read Out departmental
objectives & projects by providing laboratories, equipment’s, media,
glassware & materials with the ‘state of the art’ expected level and the
optimal support needed, by promoting Information Management Systems
developments and lab automation initiatives, by setting KPIs and operating
data management.
- guaranty that scientists and technicians are concentrated on scientific
tasks, delegating support issues to support teams.
- improve productivity, added value and cost control.
with the highest quality in accordance with cGMP's, EHS requirements and the
defined lead-times.
Key Responsibilities
Lead the Business Process Management (BPM) department (QC Lot
Release / SAP QM Master Data Management / SAP IT Project Management
and end-user support, QC KPIs & Data Management) according to
priorities, lead-times and cGMP’s.
Lead the Logistics Operations department (Material & Media preparation /
Sample & Reagents Management / Provisioning, Warehouse & Supply) to
support QC Technology (Biology, Biochemistry, or Physicochemistry), R&D
Global Clinical Read-Out and National Control Authorities (NCL) analytical
& release operations.
Lead the Infrastructure Management operations (Maintenance / Calibration
& Measurement / Analytical Systems Validation) to ensure that QC
infrastructure and analytical systems remain state of the art in term of
technology and legal constraints.
Lead the QC Demand, Planning & Capacity Periodic reviews to align
human, equipment’s & infrastructures resources to 6 months (Site D&OP),
3 years (GD&OP) and 10 Y (Strategic Planning), to ensure Business
Continuity Planning.
Lead Training & Communication academy.
2. Coordinate QC EHS initiatives and representation.
Ensure QC representation during inspection/ audits
Provide support to different departments (QC, Operations, MCoE,
Industrialization, R&D, …) for existing and new products development, as
well as investigations.
Lead technological support 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
Job Scope
Lead the QC Technological Support department in order to release
commercial and non-commercial vaccine products, to support QC
Technology, R&D GCRO and NCLs analytical & release operations and to
maintain and develop QC infrastructures at the state of the art according
to priorities, lead-times and cGMP’s.
Ensure BPM accountabilities : QC Batch release & management of UDe
(Usage Decision expected dates), good usage of SAP by mentoring &
monitoring, SAP key-users network organization, QC KPIs generation for
performance and quality needs, Master data accuracy, Proposing Business
Processes and Lab Automation improvements, (preparing Project Initiation
Form & managing implementation).
Ensure Logistics Operations accountabilities : availability and supply to QC
Technology, R&D GCRO departments and NCLs in a timely manner of
samples, materials and media with the expected quality according to
priorities and cGMP’s.
Ensure Infrastructure Management accountabilities : manage and realize
preventive, emergency, corrective and modificative maintenance,
calibration & measurements operations according to annual plans,
priorities, cGMP’s and safety requirements; manage infrastructure projects
(design, construction, implementation, validation).
Ensure availability and realization of annual Continuous Validation Plan for
analytical systems, laboratory and industrial equipment’s.
Ensure QC Demand, Planning & Capacity accountabilities : periodic reviews
to align human, equipment’s & infrastructures resources to 6 months (Site
D&OP), 3 years (GD&OP) and 10 Y (Strategic Planning) requirements; lead
of QC Business Continuity Planning (identification of solutions, annual
review, BCP Officer accountabilities)
Lead Training & Communication Academy : QC Induction Training Program
coordination, Training & Capabilities program implementation, Training
matrix standardization, QC Intranet Community Management, QC
representative for HR & QA Systems.
Lead EHS accountabilities : provide QC annual EHS Plan and monitor
realization. Organize key-contacts network. Ensure Building Manager
accountabilities.
3. Ensure that deviations are correctly managed and that adequate CAPA’s
are in place and in use.
Ensure the coordination between QC and manufacturing operations.
Time horizon
Decisions affect the short and the long term business success of GSK
Biologicals
Role impact
Lead a department of 150 People including 15% managers, 40%
technicians, 45% blue-collar workers. Lead / Manage a staff of 7-10
consultants.
Lead of a multiple-business organization with impact on QC objectives and
deliveries.
QC Usage Decision on Commercial batches, Media and Raw Materials
specific to QC operations.
Supply of samples & reagents to NCLs and other Bio sites potentially
impact release by NCLs and analytical transfer projects.
Promote technology, process and information management systems
development to improve quality, increase productivity, control costs,
reduce risks (Security & ergonomic)
Anticipate changes and adapt organization, service level agreements and
processes accordingly.
Promote focus of QC resources on high added value operations and sub-
contracting for others.
Act as a reference in term of operational, technical and QC process expertise in
GSK Bio. Strong knowledge of GSK Bio products and processes
Breadth/ Scope of Accountability
Number of Direct Report 6
Number of Indirect Reports +/- 170 fees included
Assets Managed Accountability 400 Mio €
Operating Budget Accountability 5,000 k€ (Managerial expenses)
QC Infrastructure : 4 buildings / 15,000 m² net lab surfaces / 5,000 equipment’s
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 Industrialization). Continuous
4. 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.
5. 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