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Bristol Myers Squibb
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Manager, Annual Product Quality Review (APQR)

Manager, Annual Product Quality Review (APQR)

Bristol Myers Squibb

5 - 10 years

7 - 11 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

product quality training automation process improvement pharma project management clinical trials data privacy gmp risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Annual Product Review (APQR) Manager Will primarily manage the Global BMS site APQR program by authoring and completing the APQRs for all BMS commercial Marketed Products. The APQR manager will be responsible for the completion of this annual compliance expectation by partnering with the site to draft and compete document from final approval.

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 through approval of APQRS assigned, per site APQRs per schedule
Responsible for ensuring any site or CMO APQR is created following the effective process and procedures
Responsible for updates to the APQR program requiring SOP, WI and/or training
Provide in depth quality and compliance oversight during report authoring and reviewing.
Responsible for ensuring all elements of the AQPR procedure are compliantly fulfilled.
Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders.
Responsible to escalate any deficiencies in the draft APQR which cannot be resolved with the working team
Responsible for projecting and communicating stakeholder actions and timing.
Responsible for escalation of risk to management if not meeting the completion date.
Responsible for providing opportunities for process improvement and standardization.
Supporting onboarding and training of more junior team members
Support, as 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:

Demonstrated knowledge of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes required.
Completes work with periodic check in with direct manager
Experience in a GMP Quality role required in a commercial operations setting
Demonstrated experience in authoring and completing site APQRs
Ability to drive consensus, performance and to lead strategically
Prior experience with navigating multiple Quality Management systems.
Demonstrated strategic and tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
Solid negotiating and influencing skills in a matrixed organization.
Ability to work in a global matrix environment.
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 5 years of experience in a quality, and/or regulatory role within the biopharmaceutical industry with demonstrated expertise in Quality Compliance, or Operations preferred.

Travel:

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

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Manager, Annual Product Quality Review (APQR)