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.
This position provides Quality assurance oversight and performs product disposition for biologic drug substance manufactured by external contract service providers. Primary responsibility is to lead coordination, judgment, and product quality analysis to ensure that products from external contract supplier comply with all regulatory standards and internal requirements. The candidate will ensure that the contract service provider will meet health authority expectations regarding manufacturing of BMS products. Candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of business goals.
The candidate will:
- Ensure contract service provider meets requirements on the Quality Agreement
- Review/approve change requests generated internally or by external manufacturers ensuring the change is well documented and technically sound
- Investigate and/or evaluate manufacturing and laboratory deviations or incidents. Ensure robust evaluation with sound action plans.
- Exchange with PIP members on Quality Best Practices.
- Perform “on the floor” oversight of processes including laboratory testing being executed at the contract manufacturer.
- Set example of compliance through actions. Awareness of changes to regulation and recommend changes or actions to adhere to changes.
- Write, review, approve and implement SOPs to ensure compliance with current BMS standards and CGMP.
- Review and approve validation/qualification protocols and reports for new and existing products and processes from the contract supplier as specified in Quality Agreements
- Once the product is commercialized, review performance of the product in meeting essential quality parameters through the Annual Product Review.
- Assist in preparation of audit observation responses
- Develop quality assurance network within BMS to assure alignment with BMS processes.
- Represent BMS at FDA or any HA inspections as well as BMS GMP compliance audits at the contract service provider as defined in the relevant Quality Agreements.
- In collaboration with other Biologics External Manufacturing partners, ensures contract service provider meets expectations for deviation and product disposition cycle times
- Manage and develop a staff of Quality professionals supporting manufacturing/testing at the contract service provide
Reporting to Ralf Aubeck, Dir Biologics External manufacturing Quality Qualifications:
- Hold a B.S., M.S., or PhD degree in science or engineering. Advance degree preferred
- Have at least 12 years experience in bio-pharmaceutical and/or pharmaceutical industry with at least 5 years in Quality
- Be intimately familiar with cGMP, ICH and other quality guidelines and standards and ability to interpret and apply them
- Experience in the manufacture of biologic and/or pharmaceutical drug substance and/or drug product is desired
- Fluency in English is required and fluency in Korea is desired
- BMS work location will be in Incheon South Korea
- Written and verbal skills must be excellent.
- Excellent interpersonal skills that foster cooperation and commitment.
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
- Technical proficiency for evaluation of investigations
- Must be able to prioritize multiple duties and projects.
- Proven record of leadership in a biopharmaceutical environment with effective skills in managing quality operations unit and delivering on operational requirements