Bristol Myers Squibb Associate Director, Manufacturing Investigations and Compliance in Cambridge, Massachusetts
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, Compliance and Investigations, leads a team that provides compliance and investigations support to the Devens Cell Therapy Manufacturing Facility. The Devens Cell Therapy Manufacturing Facility is a new facility and the Associate Director will build a team and establish processes for investigations, corrective and preventative actions, self-inspections, and product complaints. The Associate Director reports to the Director of Manufacturing Technology.
Responsibilities include, but are not limited to, the following:
Provides direct supervision of lead investigators and compliance leads
In partnership with Quality Assurance, establishes and executes the investigations, CAPA, Annual Product Quality Report (APQR) and product complaints programs.
Establishes and reports metrics for compliance activities (investigations, CAPAs, training % completion for compliance programs). In collaboration with Quality Assurance, Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
Establish and maintain lead investigators certification training program
Performs review and approval of site and department SOPs.
Ensure safe and compliant cGMP operations and maintains permanent inspection readiness. Actively supports regulatory inspections.
Interact with other teams including Process Engineering and Manufacturing Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities.
Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
Defines and enforces performance measures, provides developmental feedback and coaching
Create an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments
Support organizational strategic goals and objectives that are linked to the overall company strategy
Champion continuous improvement, problem solving, and incident prevention initiatives
Drive strong collaboration within the Devens Cell Therapy Manufacturing plant and across the network
Deliver business results through timely and quality decision making and advice
Qualifications and Education Requirements:
Experience in leading investigations, performing root cause analysis and identifying corrective and preventative actions
Experience in product complaints and APQRs is a plus
Experience in building and growing an organization into a high performance team
Excellent verbal/written communication skills and ability to influence at all levels
Ability to think strategically and to translate strategy into actions
Ability to prioritize and provide clear direction to team members in a highly dynamic environment
Experience with Operational Excellence and Lean Manufacturing is a plus.
Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required.
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 10 years of experience in biopharmaceutical operations with 4+ years of prior management experience
WORKING CONDITIONS (US Only):
Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.
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.
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 the resources to pursue their goals, both at work and in their personal lives.
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.
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 any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1540633
Updated: 2021-06-23 02:53:25.392 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.