Senior Manager, Quality Assurance Investigations in Devens, MA at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent
Strong background and demonstrated effectiveness in quality assurance operations
Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable
Knowledge of US and EU cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Demonstrated leadership, interpersonal, communication, and motivation skills
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process
Must be action-oriented and customer-focused and skilled in decision-making, building relationships

Responsibilities

Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of deviations, CAPA, and complaints
Provides direct supervision of personnel approving investigations and CAPA
Performs review and approval of site and department SOPs
Develop and manage the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports
Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
Directly participates in internal audits or reviews as well as global health authority inspections
Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
Establish and communicates performance objectives for Quality Assurance staff that are consistent with the company goals and objectives
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments
Provides oversight to identify and implement changes that lead to realization of long-term department goals

Skills

Quality Assurance

Investigations

CAPA

cGMP

Deviation Management

Complaints Handling

Personnel Supervision

Operating Procedures

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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