This document describes the job of a Manager, Quality Assurance. The manager leads a quality assurance audit team and ensures compliance with clinical trial standards and regulations. Key responsibilities include planning and conducting audits, identifying issues, ensuring corrective actions are implemented, and serving as an expert on clinical quality regulations. The manager must have experience with auditing, compliance activities, and standard operating procedures.

1. Aptiv Solutions Title: Manager, Quality Assurance
Effective Date: 01-Jul-2011 Job Description
Title: Manager, Quality Assurance
Levels: 2
Organization Level: Manager
Functional Area: Quality Assurance
Reports to: Director, Quality Assurance; Executive
Direct Reports: Quality Assurance Auditor
GENERAL SUMMARY
Leads QA audit team and/or manages a corporate quality management function in order to
assure compliance with the company’s or Sponsor/client SOPs, study protocols, Good Clinical
Practice guidelines, relevant regulations and other relevant requirements. Organize, conduct or
supervise internal and contracted audits and ensures they are performed, non-conformities
evaluated and followed up. Reports identified quality issues to management and to Sponsors/
clients when applicable.
ACCOUNTABILITIES
• Leads QA auditor team by providing clear team and individual goals and expectations and
ensuring that each member of the auditing staff understands her/his responsibility to know
and follow all SOPs and corporate policies
• Alternatively: Performs a specific quality management function of the company and/or
ensures that the company maintains compliance in a sphere of action that is outside of the
core GCP environment
o Manage the Computerized System Validation (CSV) activities for the company, or
o Provide specific audit skills to the Business Unit (e.g. GLP, GMP, ISO9001, etc.), or
o Assume responsibility for the company on another core function that is “non-
standard” or a rare qualification that is vitally needed for the company’s operations
o A combination of two or more of the items above.
• Ensures team objectives achieved by:
o Develop and achieve assigned objectives and budgets for auditing services;
o Efficient and effective planning, implementation, and monitoring of auditing
functions;
o Ensure auditing personnel are available and properly trained to meet the workload
needs of the company.
• Performs personally or ensures contracted and internal audits are completed according to
client expectations and current SOPs:
o Ensures audits are planned and scheduled with client input, when applicable.
o Ensures audits are conducted according to client or company SOPs to identify non-
conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for
data accuracy and completeness.
o Ensures non-conformities are reported according to client or company SOPs and
report templates.
o Ensures that responses and corrective actions are tracked, collected and reported as
per contract with client or according to company SOPs.
o Ensures closure of audits is documented as per company SOPs.
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2. Aptiv Solutions Title: Manager, Quality Assurance
Effective Date: 01-Jul-2011 Job Description
• Interprets regulations and guidance documents governing GCP and serves as expert and
consultant to staff and client representatives
o Researches the published information, interacts with other QA/regulatory
professionals and to maintain knowledge of current expectations and new trends
and proposed changes to regulations.
o Compiles response from QA staff and literature and replies to customer and more
broadly throughout company as needed.
• Performs personally and/or ensures all new and updated company SOPs (QMDs) are
reviewed by QA
o Ensures SOPs are reviewed for clarity, internal consistency, and consistency with
other related SOPs.
o Ensures the likelihood is evaluated that following the SOP as written will ensure
compliance with regulations and guidance documents and achieve required results.
• Performs personally and/or ensures client audits and regulatory inspections of company are
hosted to facilitate the audits and minimize disruptions to ongoing operations.
• Represent the company’s QA function at relevant Business Development meetings and
assist with the preparation of cost proposals and contracts.
QUALIFICATIONS
• An undergraduate degree or its international equivalent in health sciences or other relevant
disciplines from an accredited institution required
• Managerial experience in clinical research or similar area preferred
• Experience with auditing, compliance, and SOP development required
• Must have thorough understanding of EC and/or US regulations
• Understanding of all aspects of clinical research, including protocol development, CRF
design, clinical trial management, data management, statistical analysis, clinical study
reports, and regulatory submissions preferred
• Compliance or auditing management experience helpful
• Read, write and speak fluent English as well as host country language if that is not English.
Fluency in other languages is a plus
WORKING CONDITIONS
Travel: Up to 40%
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