External Manufacturing QA (R1558299-en-us-1)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Experience and Education requirements:
Minimum B.S. in related sciences.
B.S. with 8+ years experience; including 3-5 years experience in a regulated function (pharma/biotech).
Experience within manufacturing operation in pharma/biotech environment is preferred.
In-depth knowledge of GMP regulations
Strong interpersonal and organizational skills
Demonstrated leadership skills
Effective written and verbal communication
Computer literacy: Microsoft Office and other quality system
Key Responsibilities and Major Duties
Serves as the Quality single point of contact for the assigned CMOs with responsibility for Quality and Compliance performance
Reviews all batch and test documentation associated with investigational medicinal products (IMPs) and perform batch releases.
Reviews and approves all CMO investigations and change controls.
Authors, reviews, and approves documents related to EXM documentation as needed.
Authors risk assessment as required.
Provides reports to Management related to timely CAPA implementation or other issues, as requested
Partner with Technical Operations to identify and qualify manufacturing facilities for the Manufacture, Packaging and testing of Clinical Products.
Ensures Complaints, Deviations, and CAPAs are managed in a compliant and timely manner.
Oversees CMO change control process and ensures that BMS products are manufactured in full compliance with all applicable regulations.
Partners with Technical Operations to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
Quality Review and Approval of GMP Documentation: Develops Quality metrics as part of a balanced scorecard to assess ongoing monthly performance.
Final Quality approver for all GMP documentation associated with Batch Records, Investigation Protocols etc.
Responsible for final Batch Disposition decisions.
Participates in internal vendor audits.
Performs other tasks as assigned.
Must have GMP, Quality, and in-depth risk management knowledge.
Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity.
Good understanding of the GMPs as related to Clinical Manufacturing.
Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies.
Knowledge of required QP processes for Investigational Materials and expectations for International markets.
Hands-on CMC experience of clinical manufacturing. Periods spent in Clinical manufacturing operations would be considered advantageous.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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