Senior Manager, Quality Assurance Lab Operations Devens, MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 130020 - 157600
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.
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 with the resources to pursue their goals both at work and in their personal lives.
Position Summary
The Senior Manager Quality Assurance - Lab Operations is responsible for leading QA oversight of laboratory operations supporting GMP testing method validation and stability programs in a biotechnology manufacturing environment. This role ensures that all laboratory activities are conducted in compliance with applicable regulations internal procedures and industry best practices. The position plays a key role in maintaining data integrity supporting regulatory inspections and driving continuous improvement across quality control laboratories.
Key Responsibilities
Provide strategic and operational QA oversight for GMP laboratory operations including QC testing method validation and stability studies.
Lead QA review and approval of laboratory documentation such as test records method validation protocols/reports and stability data.
Ensure compliance with cGMP GLP and data integrity standards across all lab operations.
Collaborate with QC Analytical Development and Regulatory Affairs to support product release and regulatory submissions.
Manage and mentor a team of QA professionals supporting lab operations.
Lead or support investigations related to laboratory deviations OOS/OOT results and laboratory incidents.
Participate in internal audits and regulatory inspections as a QA representative and subject matter expert.
Drive continuous improvement initiatives to enhance lab compliance efficiency and quality culture.
Additional Qualifications/Responsibilities
Qualifications & Experience
Experience with electronic laboratory systems (e.g. LIMS Empower LabWare).
Strong leadership communication and interpersonal skills.
Ability to manage multiple priorities in a fast-paced environment.
Experience supporting regulatory inspections (FDA EMA etc.).
Bachelors or Masters degree in Life Sciences Chemistry or a related field.
8 years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment.
3 years of leadership or management experience.
Strong understanding of analytical testing method validation and stability programs for biologics.
In-depth knowledge of cGMP GLP ICH guidelines and data integrity principles.
The starting compensation for this job is a range from US-MA- $ 130020-$157600 plus incentive cash and stock opportunities (based on eligibility).
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Devens - MA - US: $130020 - $157559
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Senior Manager
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
