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
