Manager, QA Operations - 2nd Shift
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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. Read more: [Register to View]
Education and Experience:
Bachelor’s degree preferred, preferably in a related science.
Advanced degree desired.
7 years’ relevant work experience required, preferably in a regulated pharmaceutical environment.
2 years’ leadership experience preferred.
Experience in pharmaceutical quality unit operations and aseptic processing desired.
An equivalent combination of education, experience and training may substitute .
• Advanced knowledge of current Good Manufacturing Practices.
• Ability to lead and develop others.
• Ability to prioritize the functions and responsibilities of others.
• Must be familiar with the requirements of OSHA, DEA, USP, and EP.
• Advanced written and verbal communication skills.
• Advanced knowledge of risk management and the ability to apply the concepts of risk management effectively.
• Ability to work effectively in teams.
• Advanced knowledge of quality management standards and industry guidance on quality systems.
Duties and Responsibilities
Leads, coaches, coordinates and prioritizes the functions and responsibilities of the Quality Assurance team in support of site cGMP commercial manufacturing operations:
• Provides guidance and ensures completion of AQL inspections.
• Ensures team training is performed, adequate and completed.
• Provides routine feedback and coaching.
• Mentors team members and awards compensation commensurate with performance levels.
• Manages and adheres to the QA Department budget.
Directly leads site quality processes to ensure compliance and product quality:
• Leads site departments and QA team members in the deviation investigation process.
• Ensures control of systems, processes and product through supporting review and approval of change notices and change controls.
• Assists the QA team in the performance of the complaint investigation process.
• Ensures QA procedures and processes are maintained, adequate and efficient. • Assists and coordinates QA team member reviews of protocols and procedures.
Provides leadership to ensure site compliance with current Good Manufacturing Practices:
• Represents QA in global regulatory agency audits and inspections.
• Interfaces with quality teams within the company to include the Americas, Europe, Australia and Asia/Pacific.
• Interacts with Marketing Authorization Holders (MAH) and Marketing Partners across the globe to ensure compliance and product quality.
Leads site commercial batch record review and disposition of product for global distribution:
• Ensure commercial products meet respective quality requirements.
• Liaise with global departments and team members such as the Qualified Person (QP) to release product to market.
• Ensure quality issues or concerns are communicated and resolved in a timely manner to support appropriate product disposition.
• Maintain and evolve the product release and control process.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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