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Bristol Myers Squibb

Senior Manager, Quality Compliance (R1557768-en-us)

Technology

Development Manager

Yearly

No

Syracuse, New York, United States

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.

Summary:

Senior Manager, Quality Compliance is within the Syracuse Quality organization supporting GMP compliance and inspection/audit readiness.


Responsibilities:

  • Manage overall cGMP compliance as it relates to Quality Systems for inspection and audit readiness activities and overall cGMP compliance.

  • Identify and implement processes and systems to ensure inspection/audit readiness.

  • Participate in the site team which prepares for, hosts, and responds to regulatory inspections.

  • Responsible to deliver regulatory inspection readiness coaching and guidance.

  • Ensure alignment with BMS directives and industry guidelines.

  • Monitor, educate, and provide compliance related support to manufacturing and laboratories through direct interactions with groups in respective areas.

  • Oversee regulatory site verifications and inspectional observations, corrective actions, and inspection requests.

  • Monitor, track, and assess the effectiveness of implemented programs and make adjustments to enhance and ensure effectiveness as needed.

  • Manage the site self-inspection program.

  • Responsible for developing self-inspection schedule, leading self-inspections (including opening and closing meetings), training ad-hoc inspection team members, evaluation of observation responses, tracking the responses and corrective actions, and performing quality metrics related to self-inspection findings.

  • Assist in managing Biologic Product Deviation Reports, Quality defect notification, and the Market Action Fact Finding process.

  • Drive continuous improvement initiatives through participation in process and system improvements at the site and network levels.

  • Exercise sound judgement in assuring compliance with regulations, practices, and policies.

  • Interpret regulations and maintains an awareness of evolving regulations.

  • Develop an ability to understand changing regulations and apply knowledge of best industry practices.

  • Apply Quality Risk Management principles to improve prioritization and decision-making to drive inspectional

  • performance.

  • Maintain the site master file.

  • Coordinate with Regulatory contacts to provide information or supporting documentation for Regulatory actions and submissions.

  • Serve as the Syracuse site Global Regulatory Observation Evaluation (GROe) Ambassador.

  • Support site and global data integrity programs.

Qualifications:

  • Bachelor’s degree, M.S., or PhD and at least 10 years relevant experience in the bio-pharmaceutical industry, with a minimum of 5 years’ experience in Quality Assurance or related technical function and increasing cross-functional responsibility.

  • Ability to communicate complex information clearly and concisely.

  • Demonstrate knowledge of subject matter related to quality and compliance.

  • Ability to create a team based, collaborative environment.

  • Ability to shape the culture by demonstrating examples of compliance behaviors and attitudes.

  • Display the flexibility, confidence, and decisiveness to effectively establish proper priorities and manage through the dynamic of frequent change.

  • Support the corporate culture to promote professional and performance excellence.

  • Detail-oriented with a sense of urgency for completing tasks.

  • Demonstrate excellent organizational skills and ability to effectively prioritize work.

  • Ability to perform tasks completely and independently and complete assignments without detailed direction.

  • Excellent communication, technical writing, and computer skills.

  • Demonstrated knowledge of a variety of computer software applications in word processing, spreadsheets, and database software.

  • Technical knowledge related to manufacturing and laboratory testing required.

  • Experience with working in/supporting concurrent manufacturing is required.

  • Experience leading cross-functional teams with demonstrated success is required.

  • Superior interpersonal skills to facilitate the development of effective partnering relationships with a diverse array of individuals including counterparts in partner groups, peers, and team members

  • An extensive knowledge and understanding of FDA, EU, ICH, PIC/S and Japanese guidelines, and cGMP.

  • Must have project management skills with the ability to lead cross-functional problem-solving teams.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.