Senior Specialist, Annual Product Quality Review (APQR) at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Understanding of Biologics, Pharmaceutical, and/or Cell Therapy operations and processes
Experience in a GMP Quality role
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
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
Ability to travel

Responsibilities

Manage the Global BMS site APQR program by leading and generating APQRs for all commercial Marketed Products
Lead a team of Subject Matter Experts to draft and complete APQRs from draft to final approval and delivery to key stakeholders per schedule
Provide oversight and completion of site APQRs
Author assigned site APQRs per schedule
Ensure site or CMO APQRs are created following effective processes and procedures
Provide in-depth quality and compliance oversight during report authoring
Ensure all elements of the APQR procedure are fulfilled accurately
Facilitate review and approval meetings, problem-solve key issues, and manage communications with key stakeholders
Collect review feedback and resolve comments and questions
Project and communicate stakeholder actions and timing
Escalate deficiencies in the draft APQR that cannot be resolved with the working team
Escalate risks to not meeting the completion date
Provide opportunities for process improvement
Adhere to GMPs and BMS Policies and Procedures
Support implementation and/or maintenance of additional QA Systems (e.g., APQR program documentation, Change Control, Quality Risk Management, Product Quality Complaints)
Support digitalization/automation efforts for the APQR program

Skills

APQR

Annual Product Quality Review

Quality Oversight

Compliance

Report Authoring

Stakeholder Management

SME Coordination

GMP

Pharmaceutical Manufacturing

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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