Senior Manager Quality Operations ExM Americas
Location
Jersey | United Kingdom
Job description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Our Global Quality team has an unwavering commitment to achieving precision and excellence right from the start. Our Culture of Excellence is the driving force behind the execution of our strategy, it is not only about adhering to protocols; it is about embodying a mindset that pursues excellence in every action. By nurturing a culture of continuous improvement, we consistently refine our processes, pushing the boundaries of innovation. At BMS we empower our employees to visualize, address, and resolve challenges from within, fostering a sense of ownership and empowerment that resonates throughout our organization. Our triumphs are a testament to our ability to assemble teams of forward-thinking, innovative, and passionate professionals who collectively propel us to new horizons.
The
Senior Manager, Quality Operations ExM Americas manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by standard operating procedures ( SOP s) , authoring and executing Risk Mitigation Plans as needed.
Responsibilities: - Determine disposition of drug products according to BMS and regulatory specifications and standards
- Review / Approve change requests generated internally or by External Manufacturer
- Review Annual Product Quality Reviews ( APQRs ) authored by Contract Manufacturers /Packagers and supplement APQR as required
- Investigate and/or evaluate manufacturing , packaging and laboratory deviations or incidents and associated Corrective Actions and/or Preventive Actions ( CAPAs ) . Provide direction and recommendations as to future course(s) of action
- Review and approve Quality Agreements as required
- Approve product quality complaint investigations
- Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
- Write, review and implement SOPs to ensure compliance with current BMS standard and current Good Manufacturing Practices ( cGMP )
- Serve on Fact Finding Investigation Team (FIT) and Fact Finding Investigation Review Meetings (FIRM)
- Support product recalls and execute plan as assigned
- Represent Bristol-Myers Squibb during FDA/other regulatory inspections and corporate Good Manufacturing Practices ( GMP ) compliance audits as defined in related Quality Agreements
- Assist with preparation of audit observations
- Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and European Medicines Agency ( EMA ) agency cGMP regulations and policies
- Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing , Packaging l aunch teams
Knowledge & Skills: - 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
- Proficiency with the use of global systems (e.g., Systems, Applications and Products ( SAP ) , Document Control and Archiving ( DCA ) )
- 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
- Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems
Basic Qualifications: - B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
- A minimum of 7 years ’ experience in pharmaceutical, biologics, biotech or related industry with relevant experience
- Experience in a Quality Assurance , Quality Control or equivalent function is required
Preferred Qualifications: - Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
#LI-Hybrid
VETERAN
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to
[email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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