Bristol-Myers Squibb Company

Contract Testing Lab QA

Location
New Brunswick, NJ, US
Posted
Jan 29, 2019
Ref
R1513191_EN
Required Education
Doctorate/PHD/MD
Position Type
Full time
The CTL Quality Assurance reports directly to the Director, Product Development and Clinical Supply Quality and is responsible for the quality oversight of release and stability testing for products performed at a contract testing laboratories(CTL). This position will provide services to other BMS functions such as internal GPS (Global Product Development and Supply) sites and commercial GPS Quality.
  • Develop and implement processes/procedures for oversight of contract testing laboratories to ensure compliance with regulatory requirements and expectations
  • Review and approve GMP documentation generated by contract testing laboratories ensuring documentation is well written, technically sound, and compliant with regulatory expectations
  • Investigate/evaluate lab deviations to ensure thorough root cause analysis. Provide direction and recommendations as to future courses of action.
  • Responsible and accountable for Quality Agreement development, negotiations, and maintenance.
  • Develop and maintain metrics on lab service levels to drive continuous improvement with CTL
  • Develop and maintain communication systems with all BMS customers that use contract testing laboratories for testing
  • Align and maintain collaborative partnership with internal BMS Analytical functions.
  • Partner with other functions to provide aligned oversight of laboratory testing at CMOs.


Qualifications:

Education Requirement

PhD degree with minimum of 5 years or MS degree with minimum of 7 years or BS degree with minimum of 10 years of experience in pharmaceutical/biotechnology industry.

Minimum of 3 years in Quality Assurance role.

Experience/Knowledge/Skill set:

Demonstrated knowledge and understanding of analytical test methods for biologic products

Demonstrated knowledge of regulatory and compliance expectations (cGMP, ICH and other quality guidelines).

Work experience in a Quality Control laboratory preferred.

Personal Competencies Desired/Required:

Strong strategic and analytical thinking, problem solving and rapid decision making skills.

Strong ability in negotiating and influencing without authority in complex, high impact situations.

Ability to assess the right balance between the business implications, technical considerations and quality decisions.

Demonstrated ability in technical writing, computer knowledge and communication skills is required.

Travel may be required, including some international