Associate Director Quality Compliance
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.
The Associate Director of Quality Systems Compliance is a full-time position located at the Bothell Manufacturing Plant (Jump) located in Bothell, Washington. The primary focus for this role is to lead the Quality Systems Compliance team to ensure the site is inspection ready and key compliance programs at the site such as self inspection program and inspection readiness and management are implemented and maintained. This individual will work cross-functionally and within the Cell Therapy network to support continual improvement initiatives for these programs to ensure compliance with applicable policies and standards.
Education: Bachelors Degree
- A minimum of 10 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment.
- Experience leading and performing internal or third party audits
- Management and participation in health authority inspections
- Experience in building end to end inspection readiness programs 1-2 year management experience
- ASQ Auditor Certification preferred, but not required
Role and Responsibility:
- Lead team that coordinates the end to end inspection readiness activities, including preparation and strategy sessions, interaction training for subject matter experts, and managing audit and inspection related logistics
- Ensure site personnel readiness by scheduling and conducting mock review sessions with subject matter experts
- Coordinate cross functional activities focusing on development, review, approval and submission of responses for inspection and audit findings
- Monitor and report status of remediation actions resulting from audit and inspection findings and drive efforts to ensure on-time completion
- Publish and report audit and inspection metrics in accordance to Quality Council Requirements
- Review, analyze and distribute regulatory inspection data and trending issued by regulatory authorities to ensure proactive compliance across the organization
- Develop and manage the inspection readiness annual plan, including identification of anticipated inspections
- Develop and manage the site self inspection schedule and ensure adherence to schedule.
- Coordinate document requests to support Health Authority Submission
- Coordination and submission of Biologic Product Deviation Reports
- Coordination and management of site notification to management program
- Identification and execution of continuous improvement initiatives within the Quality Systems Compliance programs
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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