BMS is a global biopharmaceutical company committed to improving the lives of patients worldwide. At BMS, we seek to deliver truly innovative and life-changing treatments for our patients
Our Vector CMO Quality Assurance team is responsible for overseeing and supporting external manufacturing operations of our global CMO partners. The Senior QA Specialist position is an individual contributor role responsible for providing QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards.
Primary Responsibilities include:
- Partner closely with BMS External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners where assigned as VQM.
- Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
- Effectively communicate issues, risks and proposed solutions within the organization.
- Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
- Provide communication, support, and guidance to manufacturing partners and within the QA CMO team.
- Facilitates implementation of policies and procedures for CMO compliance; including development of Quality Agreements, Quality Business Processes, Product Disposition and Quality Event Resolution in accordance with team derived strategy and business realities.
- Perform batch record review and lot disposition activities as required.
- Proven ability to work effectively in a matrixed organization
- Support internal and external audits as needed
- Create and revise Standard Operating Procedures as needed.
- Other duties as assigned.
- Up to 30% travel.
8+ years of experience in a GMPs environment. Must have Bachelor’s degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.
- 8+ years related industry experience with a minimum of 3 years’ experience in quality assurance, quality control, and compliance.
- Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
- Strong organizational skills, including ability to follow assignments through to completion.
- Experience influencing and negotiating.
- Knowledge of relevant regulations and guidance documents for Cell Therapy products.
- Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decisions.
- Excellent verbal and written communication skills.
- Detail-oriented with skills in problem solving and solid decision making abilities.
- Experience within the Cellular Therapeutics and/or gene based products.
- Experience with Commercial products manufacture, supply and post-approval change management
- Experience providing oversight to external suppliers and other supply chain issues.
- Strong project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.