Associate Director, MSAT - Compliance and Investigations

Company: Disability Solutions
Location: Bothell
Posted on: October 8, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: .Position Summary The Associate Director, Compliance and Investigations, leads a team that provides compliance and investigations support to the Bothell Cell Therapy Manufacturing Facility. 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 Senior Director of Manufacturing Sciences and Technology . Required Competencies: Knowledge, Skills and Abilities

• Experience leading investigations, performing root cause analysis, and identifying corrective and preventative actions.
• Experience in product complaints and with writing sections of APQRs and/or documents used in regulatory filings is a plus.
• Experience in building and growing an organization into a high performing 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/Six Sigma and Lean Manufacturing is a plus.
• Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Experience in cell therapy, biologics, or vaccine manufacturing/support required. Duties and Responsibilities:
  • 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.
  • Represents the Site MSAT Investigations team in cross-functional forums & projects.
  • Performs review and approval of site and department SOPs.
  • Hires, integrates, and develops high quality talent who are capable of delivering against the site & department goals and objectives.
  • Defines and enforces performance measures; provides developmental feedback and coaching.
  • Creates an environment of teamwork, open communication, and a sense of urgency which enhances unit performance and integration across site departments.
  • Supports organizational strategic goals and objectives that are linked to the overall company strategy through analytical & risk-based thinking; Makes recommendations and implements actions to meet strategic goals & objectives.
  • Drives the development of efficient, consistent processes, and builds a workplace culture of continuous improvement through strong problem solving/creative skills.
  • Identifies and recommends improvements to the organization, processes, procedures, and the Quality Management System.
  • Delivers business results through timely, quality, and risk-based decision making and advice. Reporting Relationship: The Associate Director, MSAT Cell Therapy Compliance and Investigations, reports to the Senior Director, Manufacturing Science & Technology (MSAT). Qualifications and Education Requirements:
    • Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, or its equivalent is required
    • A minimum of 8 years' experience in biopharmaceutical operations with 2+ years of prior management experience required, or equivalent combination of experience and education. The starting compensation for this job is a range from $166,000 to $208,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our .Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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