Senior Manager, Quality Assurance Engineering
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
PURPOSE AND SCOPE OF POSITION:
The role is responsible for Quality oversight of Technology Transfers and Facility/Utility/Equipment/IT qualifications activities in accordance with BMS policies, standards, procedures and global cGMPs in a fast-paced, highly collaborative clinical manufacturing facility producing cell therapy CAR T and engineered T Cell products for first-in-human and early phase trials. Functional responsibilities include but not limited to quality/compliance oversight of Technology Transfer activities into and out of the site; accurate and timely maintenance and review of validation and qualification documents for all IT, equipment, utility and facility activities; accurate and timely review of investigations and evaluations of change controls; support site’s data integrity initiatives; and supports site’s Quality Risk Management program.
DUTIES AND RESPONSIBILITIES:
- Responsible for Quality oversight of technology transfers and Facility/Utility/Equipment/IT qualifications in early-phase pre-clinical and clinical setting.
- Manage QA Engineering team and assures job objectives are met on a timely basis.
- Oversee technology transfer activities and ensure compliance with global and regulatory requirements. Functions include but are not limited to the following:
- Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
- Support of the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
- Assurance that procedures are adequate to review and confirm appropriateness of data.
- Review and approval of technology transfer related deviations/discrepancies.
- Assurance that process and method transfers, method qualifications/verifications, and operator/analyst trainings meet company and regulatory requirements.
- Oversee routine support activities and site projects to ensure site is compliant with local and global requirements, as applicable. Functions include but are not limited to the Quality oversight of the following:
- Calibration/maintenance programs, validation plans, qualification protocols, and associated reports and procedures where applicable.
- Media simulation activities to ensure successful execution and documentation.
- Site is compliant with global and regulatory data governance and data integrity requirements.
- Process improvements to remove inefficiencies, improve quality and optimize productivity.
- Development of training and other documents designed to educate and improve consistency, quality, and efficiency in performing routine and non-routine functions.
- Display Leadership Qualities
- Creates an environment of teamwork, open communication, and a sense of urgency.
- Promotes a mindset of continuous improvement, problem solving, and prevention.
- Builds trust and effective relationships with peers and stakeholders.
- Drives improvements to remove inefficiencies, improve quality and optimize productivity.
- Develops and authors training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have strong GMP, Quality, and in-depth risk management knowledge.
- Critically assess project(s) and allocate resources to efficiently achieve goals. Implement solutions independently.
- Manage conflict and issues with internal and external customers. Demonstrate coaching and negotiation skills in internal and external cross-functional teams.
- Effectively communicate internally within the function and with internal and external cross-functional teams.
- Must be skilled in planning and organizing, conflict management, coaching others, talent selection, coaching and developing others, decision-making, building relationships, innovation management, and resource allocation.
- Guide, coach and develop employees of varying experience, from specialists to senior managers.
- Contribute to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
- Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must routinely recognize and resolve Quality issues; proposed solutions; develop procedures.
- Must be able to interpret complex results and situations with independence and articulate recommendations for solutions. Recognize risks and develop contingency plans. Negotiate solutions cross-functionally.
- Drive continuous improvement and increase efficiency and productivity.
EDUCATION AND EXPERIENCE (As Applicable):
- B.S. degree required.
- Minimum 9 years relevant work experience and minimum 3 years of leadership experience
- Equivalent combination of education and experience acceptable.
WORKING CONDITIONS: (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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 email@example.com. Visit careers.bms.com/eeo-accessibility 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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