Career Opportunities

Associate Director QA Operations

Posted on: Wednesday, July 29, 2015
Organization: Bristol-Meyers Squibb
Location: Syracuse, NY
Description:

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.

The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY.

The Associate Director QA Operations will manage and lead the QA Release team, QA Field group and QA Manufacturing Investigations group to ensure timely release of production materials, and incoming release of raw materials and components.

Direct QA oversight of manufacturing operations, and review and approval of quality event investigations, and supplier and materials qualification. Manage the execution of defined processes that confirm the quality of manufactured products is in compliance with all applicable regulations and guidance.

1. Has final decision authority and accountability for Bulk Drug Substance disposition for both commercial and clinical materials at Syracuse.

2. Manages team that performs raw material QA disposition

3. Owner of Quality System for Investigations

4. Develops, implements and directs operating procedures for the site quality assurance program which assures effective shop- floor quality presence; material release (raw and in-process materials as well as finished product); investigation and resolution of deviations, CAPA, and complaint investigations.

5. Co-lead the site team which prepares for, hosts and responds to regulatory inspections, and regulatory reviews of the facility and products.

6. Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.

7. Ensures that all QA Operations personnel have adequate training, education and experience to perform their GMP related job function effectively.

8. Manages staff that reviews and approves all executed batch production records and laboratory testing results before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated.

9. Participate in BPDR investigations as required.

10. Performs shop floor and lab walk through audits and challenge adherence with area procedures. Provide coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.

11. Ensure alignment with BMS directives and industry guidance on biologics manufacturing, validation and quality.

12. Manage and execute operating procedures for the site quality assurance program which assures effective shop- floor quality presence; investigation and resolution of deviations, CAPA, and complaints investigations.

13. Provide quality oversight of start-up activities including approval of master and executed production batch records, and associated process, documentation.

14. Oversee and provide guidance to the Field Quality team, ensuring open internal/external communication and timely/collaborative issue resolution.

Requirements:

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 product release, quality assurance operations and compliance of commercial biologics in a 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 sound judgment 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 is needed
  • Knowledge of Delta V and Syncade is desirable.

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 and organization is desirable.

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% of travel

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