Associate Director, Compliance

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION SUMMARY:

The Associate Director of Compliance will manage and lead the QA Compliance team responsible for the Quality Systems. They will provide leadership for change control, auditing, quality agreements, and ensure alignment of site procedures to corporate policy and directives and regulatory guidance. Drive continuous improvement in site quality systems.

Duties/Responsibilities:

• Owner of the Quality System for change control, quality agreements, audits and regulatory inspections and communications, and metrics.
• Accountable for administration and management of Trackwise.
• Oversee the completion of policy and directive updates and ensure alignment of site procedures.
• Identifies and drives changes to enhance the effectiveness of systems that manage change control, deviations, and CAPA.
• Exercises sound judgement in ensuring compliance to regulations, guidance, and policies.
• Maintains currency with interpretation of regulations and guidance and applies knowledge of industry best practices.
• Communicates complex information clearly and concisely demonstrating knowledge of quality and compliance.
• Oversees the site self-inspection program and site supplier audit program
• Hosts and facilitates all external audits and inspections, and coordinates all inspection responses and external agency responses.
• Manages significant event notifications, inclusive of market action fact finding reviews and any regulatory notification requirements.
• Ensures that all QA compliance personnel have adequate training, education, and experience to perform their GMP related job function effectively.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Expert knowledge of FDA, EU, and ICH regulations and guidance and cGMPs
• Strong root cause investigation knowledge and experience leading high-level compliance investigations.
• Strong background and demonstrated effectiveness in quality systems, quality assurance operations and compliance of commercial biologics in FDA regulated environment.
• Demonstrated leadership, interpersonal, communication and motivation skills
• Ability to understand topics which are often complex and technical in nature with an ability to apply sounds judgement and appropriate quality risk management principles in the decision making process.
• Strong communication skills and experience in preparing for and interacting directly with regulatory and external inspection auditors
• Knowledge of biologics bulk and finished product manufacturing and analytical testing is highly desirable
• Knowledge of SAP, LIMS, Maximo, and Trackwise or equivalent quality systems in needed.

Education/Experience/ Licenses/Certifications:

• BSc in science, biochemistry, engineering, or related discipline
• At least 10 years experience in pharmaceuticals or biologics industry with at least 5 years in Quality Assurance and increasing management responsibility

Experience in building, growing, and transforming an organization is desired.

Physical Demands:

Primarily an office based position requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists.

Work Environment:

Primarily office space. Occasional exposure to both manufacturing and laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents

Travel:

This position may require 10-15% travel.

Supervisory Responsibilities:

This position has direct reports.

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 the resources to pursue their goals, both at work and in their personal lives.