Sr. Spclst, Quality Systems & Compliance

Job Description

The Senior Specialist, Quality serves as a member of a team responsible for instituting consistent practices across the Durham facility in the disciplines of Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.

The Senior Specialist, Quality Assurance will be primarily responsible leading the Deviation and CAPA management systems. The role is responsible for leading the local community of practice and representing Durham in the global communities of practice associated with the indicated quality systems.

General Profile:

• Monitor standard work within the assigned quality systems and implement improvements to adherence to compliance requirements

• Direct support of regulatory inspections and audits, including presentation/defense of Deviation and CAPA Management systems during regulatory inspections.

• Metrics reporting and development in support of Quality Council

• Lead site Community of Practice (CoP) providing relevant ongoing system updates and facilitate collection of feedback to share within the global CoP.

• Make decisions guided by policies and procedures that impact the unit’s ability to meet performance objectives

• Influence stakeholders across various departments and levels, fostering collaboration and alignment on quality initiatives

• Support of site deviation management huddles, as needed

• Perform SOP development, review, and/or quality approval

• Assist in Permanent Inspection Readiness projects

• Other duties as assigned by Management.

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Minimum Educational Requirement and Experience:

• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, Engineering or other relevant scientific discipline

• Minimum of five (5) years experience supporting pharmaceutical manufacturing/quality management systems

• Demonstrated ability to independently manage multiple priorities, ensuring timely completion

• Drives results, escalation of issues / concerns to management, as appropriate.

Preferred Experience and Skills:

• Technical writing skills

• Quality systems experience

• Pharmaceutical vaccine manufacturing experience

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.