Senior Manager, Quality Assurance Investigations in Devens, MA

Bristol Myers Squibb • Devens, MA

55d • Onsite

About The Position

The Senior Manager, Quality Assurance Investigations at the Cell Therapy Facility (CTF) in Devens, MA will be 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.

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
• Strong background and demonstrated effectiveness in quality assurance operations.
• 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, able to anticipate Quality issues and proactively solve problems.
• 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.
• Demonstrated experience with electronic system and databases.
• Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
• A minimum of 8-12 years' experience in biopharmaceutical operations with prior management experience required. Equivalent education, experience or demonstrated competency will be considered.
• Experience in building and growing an organization into a high-performance team.

Nice To Haves

• Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable.

Responsibilities

• 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

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees