QA Manager

In support of the clients diverse portfolio, strong pipeline and the patients that we serve, the Quality organization provides end-to-end Quality oversight across a complex and expansive global footprint. Whether it is supplying an early phase clinical trial, manufacturing a commercial product, or distributing product in market, the Quality organization plays an important role to ensure the client provides safe, quality products to patients in a compliant way.

External Supply Quality provides Quality oversight to the external manufacturing portfolio across DS, DP and FDP for small and large molecule.

Key Responsibilities:

• Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA)
• Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.
• Owner and approver of GMP/GDP QMS documents
• Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.
• Preparation and periodic review of Bona Fides
• QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
• QA approval of change control proposals (third party contractors and internal) and action plans.
• Coordinate mock recall task force team to test the recall process in accordance with governing procedures and issuance of report with recommendations and corrective action plans for any deficiencies identified.
• Support OpEx programs and champion continuous improvements and initiatives

Authority:

• Own Quality record content
• Work under minimal direction
• Identify opportunities and issues, then determine when escalation is necessary
• Proposes revisions to SOPs in area of responsibility

Basic Qualifications:

• Doctorate degree OR
• Master's degree & 2 years of directly related experience OR
• Bachelor's degree & 4 years of directly related experience OR
• Associate's degree & 10 years of directly related experience OR
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor's Degree in a Science Field
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to travel +/- 10% of time to domestic and international sites