Manager, Quality Systems EXT MFG
About the Job
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY.
- Responsible for ensuring standard systems and processes are in place to support the Americas External Manufacturing organization. These include but not limited to systems for audits, change control, investigations, metrics, complaints, SOPs and GMP training.
- Performs site verification of SOPs and practices versus HQ policies, directives and regulatory agency observations. Manages department SOPs, including periodic review schedule.
- Manages product quality complaint process and ensures timely closure of complaint investigations
- Acts as change control gatekeeper when needed.
- Develops training curriculums for department and assists with training new employees.
- Manages Annual Product Quality Reviews schedule.
- Leads coordination and delivery of monthly Quality Council within ExM Americas.
- Tracks and reports Quality metrics on monthly basis.
- Leads coordination and execution of internal self-inspection audit program. Acts as lead auditor when assigned. Identifies and trains others to be auditors.
- Represent Bristol-Myers Squibb during FDA/other regulatory inspections and corporate GMP compliance audits.
- Leads back room during audits of ExM Americas.
- Assist with preparation of audit responses.
- Selects and retains staff. Accountable for allocating resources such that the right person is doing the right work at the right time. Develops and mentors staff. Provides feedback on performance against predefined objectives.
- B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
- A minimum of 7 years’ experience in pharmaceutical, biologics, biotech or related industry with relevant experience.
- Experience in a Quality Assurance or Quality Control function is required.
- Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired.
- Knowledge in solid dosage forms, parenteral technology, biologics, or combination products.
- Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them.
- Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.
- Proficiency with the use of global systems (e.g., TrackWise, SAP).
- Good verbal and written communication skills essential.
- Excellent interpersonal skills.
- Capable to manage multiple priorities.
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
- Exhibits BMS BioPharma behaviors.