Sr. Manager, GMP Quality

Conducts product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, release and stabilitytesting documentation, and batch disposition. Responsible for communicating with the Quality and Production departments at domestic and international contract manufacturingorganizations, and within CLIENT's Quality, Supply Chain, CMC, and Commercial Manufacturingdepartments.

Duties:
 

• Be the QA representative on cross-functional project teams.
• Responsible for communicating with the Quality and Production departments at domestic and international contract manufacturingorganizations, and within CLIENT's Quality, Supply Chain, CMC, and Commercial Manufacturingdepartments.
• Conducts product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, release and stabilitytesting documentation, and batch disposition. These activities must be conducted in a timely manner to ensure continued product supply while ensuring Quality and Safety of the product.
• Partners with CMC and Commercial Manufacturing to conduct technical transfers and validation ofnew or existing processes and products to domestic and international contract manufacturing organizations.
• Supports commercial validation activities by reviewing validation protocols and reports.
• Ensures compliance to existing procedures and supports continuous improvement opportunities by identifying areas where improvements and efficiencies can be gained through SOP and compliancestandard revisions. Authors, reviews and approves standard procedures and electronic systems, asneeded.
• Leads, authors, reviews and/or approves CMOs Quality Events, Investigations, CAPA, Change Controls, and Complaints, as well as initiating in CLIENT's eQMS, as needed. This may require timely interface with domestic and international suppliers.
• Serves as Person-in-the-Plant, as needed.
• Authors relevant sections of Annual Product Reviews by compiling appropriate data and metrics and making appropriate recommendations.
• Other duties as assigned.

Skills:

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage formsand/or combination products.
• Experience with managing external CMOs, contract laboratories, and third-party logistics suppliers.
• Must have experience in reviewing and approving master and executed batch records and performing final disposition of drug substances and products.
• Experience managing quality events (investigations, CAPA and change control), and working knowledge of formal risk management tools and assessments. The individual must demonstrate the ability to evaluate and assess technically complex quality events, as well as the ability to document these events with excellent technical writing skills.
• Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
• Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
• Excellent verbal and written communication skills, including ability to interact effectively with senior management, partners, and project core team members.
• Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of quality and compliance.

Education:

• Minimum of Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or relevant field of study.
• 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.