Senior Manager, Quality Assurance Investigations
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.
Bristol Myers Squibb is seeking a QA Senior Manager of Investigations for the Quality Sciences and Technology organization at the Cell Therapy Facility (CTF) in Devens, MA. The QA Senior Manager is responsible for providing quality oversight of the site investigations and CAPA programs and provide supervision of personnel approving investigations and CAPA at the CTF in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP.
- Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of deviations, CAPA, and complaints.
- Provides direct supervision of personnel approving investigations and CAPA.
- Performs review and approval of site and department SOPs.
- Develop and manage the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports.
- Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
- Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
- Directly participates in internal audits or reviews as well as global health authority inspections
- Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
- Establish and communicates performance objectives for Quality Assurance staff that are consistent with the company goals and objectives
- Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments
- Provides oversight to identify and implement changes that lead to realization of long-term department goals
Qualifications and Education Requirements
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
- A minimum of 6-10 years’ experience in biopharmaceutical operations with prior management experience required
- Experience in building and growing an organization into a high performance team.
- Strong background and demonstrated effectiveness in quality assurance operations.
- Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge and proven experience in FDA, EMA, or other regulatory authority.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Must possess an independent mindset and tenacity.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Is recognized Subject Matter Expert within the group.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to effectively multi-task.
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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