Senior Specialist, Annual Product Quality Review

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. 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: .

Key Responsibilities

As an Individual contributor:

The Annual Product Review (APQR) Specialist -Will primarily manage the Global BMS site APQR program by leading and generating the APQRs for all commercial Marketed Products. The APQR specialist will be responsible for the completion of this annual compliance expectation by leading a team of Subject Matter Experts to draft and compete document from draft to final approval and delivery to the key stakeholders in alignment with the prescribed schedule.

The APQR specialist will be responsible for the following defined roles and responsibilities:

• Responsible to provide oversight and completion of the site APQRs
• Responsible for authoring of APQRS assigned, per site APQRs per schedule
• Responsible for ensuring any site or CMO APQR is created following the effective process and procedures
• Provide in depth quality and compliance oversight during report authoring.
• Responsible for ensuring all elements of the AQPR procedure are fulfilled accurately.
• Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
• Responsible for collecting review feedback and resolving comments and questions.
• Responsible for projecting and communicating stakeholder actions and timing.
• Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working team
• Responsible for escalation of risk to not meeting the completion date.
• Responsible for providing opportunities for process improvement.
• Accountable to adhere to GMPs and BMS Policies and Procedures
• Support as may be required, the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) APQR program documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews
• Support as required Digitalization/automation/efforts for the APQR program

Qualifications & Experience

Specific Knowledge, Skills, Abilities:

• Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
• Works with the routine oversight on direct manager.
• Experience in a GMP Quality role required
• Experience in authoring APQRs
• Prior experience with navigating Quality Management systems.
• Demonstrated tactical thinking capability with strong project management skills.
• Ability to work in a global environment.
• Demonstrated negotiating and influencing skills in a matrixed organization.
• Ability to build strong relationships by being transparent, reliable, and delivering on commitments.
• Effective communication skills.
• Ability to provide innovative ideas, align and make decisions balancing speed, quality, and risk.
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.

Education:

• Minimum 3 years of experience in a technical, quality, and/or regulatory role within the biopharmaceutical industry with demonstrated acumen in Quality Compliance or Operations preferred.

Travel:

• Must have ability to travel to US required (specifically for training purposes)

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit 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.

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