Director, Commercial QA leads commercial activities at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure overall compliance that facilitates disposition, regulatory fillings and supply of Coherus Commercial products.
Principal Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:
- Strong knowledge base and direct experience for Commercial Drug Substance/API production and QA oversight. Experience in Drug Product and Final Packaged Product production a plus.
- Lead Quality and Compliance inititives for DS CMO that ensure the timely disposition of Commercial products in support of company objectives.
- Review and approval of master batch records to support the disposition of Coherus commercial products.
- Responsible for final release activities for commercial products.
- Responsible for final approval of Change Controls, Deviations and CAPAs for Commercial QA.
- Participate/Lead regularly scheduled meetings with CMO – both specific to QA and with cross-functional groups.
- Identify and ensure timely communication/escalation to Sr. Management for product quality issues - including escalation to Product Quality Review Board (PQRB), Quality Management Review (QMR) and Product Quality Review (PQR) forums.
- Jointly lead Coherus BioSciences’ vendor management performance metrics at CMOs with Coherus Technical Operations group.
- Direct the development of Commercial QA processes and SOPs including support for development of processes and SOPs by process owners outside QA.
- Maintain and drive process improvements to ensure the effectiveness of the Coherus Quality Management System (QMS) including but not limited to:
- Change Control
- Commercial Batch Review/Release
- Lead Quality audits of Coherus CMOs and Suppliers.
- Identify, maintain, and team with stakeholders across the organization & at CMOs to address compliance related issues and processes.
- Lead activities to ensure CMOs are compliance ready for regulatory inspections and monitor inspection progress during inspections.
- Participate in CMC teams supporting the ongoing regulatory status/filings of Coherus commercial products.
- Establish, maintain and report internal metrics to evaluate Quality performance for Commercial products.
- Train new QA staff as required.
- Support Quality Sr. Management with other duties, as required.
Experience, Education, Training, Traits:
- Bachelors of Science degree or work experience equivalent to a minimum of 10-12 + years (Mfg/QA) experience in the pharmaceutical/Biological industry, with experience in drug substance, drug product and final packaged product.
- Minimum of 7 years of experience in managing CMOs and driving process improvements.
- Prior experience in disposition of Commercial products.
- Strong Knowledge of FDA guidelines and regulations regarding cGMPs.
- Strong knowledge and demonstrated practice of ICH Guidelines.
- Exercise sound and independent judgment and decision making.
- Excellent interpersonal and communication skills.
- Exceptional attention to detail.
- Strong computer skills, including all MS Office applications.
- Exceptional ability to partner cross-functionally with different teams and projects.
- Strong initiative and ability to assume significant project management skills.
- Ability to work in a fast-paced, dynamic environment.
- Up to ~25% Travel required for this position, typically campaign based.