Sr Manager QA Technical Operations

Bristol Myers Squibb•Devens, MA

1d•$130,020 - $157,559•Onsite

About The Position

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: careers.bms.com/working-with-us. PRINCIPAL OBJECTIVE OF THE POSITION: Provide Leadership to a team of Quality managers with oversight and support for Quality Control projects as well as daily activities. Manages and oversees operations for Cell Banking, Local Site Change Controls, QA for Technology Transfer, QA for Automation and QA for Validation, and QA for MS&T and Site Engineering Maintenance programs. May assist in preparing for and hosting of regulatory and customer audits.

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 8 years’ experience in biopharmaceutical operations with 2 years of prior management experience desirable
Experience in building and growing an organization into a high-performance team.
Strong background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing.
Knowledge of biotech bulk and finished product manufacturing, and analytical testing 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.
Knowledge of applicable business systems including SAP, LIMS, Maximo, Syncade, DeltaV and Veeva Vault.
Bachelor´s degree in science, engineering, or other related discipline.
A minimum of 5 years' experience in biopharmaceutical quality or its equivalent with an additional 2-3 years of increasing responsibility.
Experience and a demonstrated track record of success leading teams with a wide range of responsibilities.
Ability to develop and lead a team of professionals who can interact across all levels and functions of the organization effectively.
Excellent written & oral communications skills.
Capability to build alignment with peer level business partners.
Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
Demonstrated capability with ability to make and act on decisions while balancing speed, quality and risk.
Knowledge of biotech bulk and finished product manufacturing, analytical testing highly desirable.

Nice To Haves

2 years of prior management experience desirable
Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
Knowledge of biotech bulk and finished product manufacturing, analytical testing highly desirable.

Responsibilities

Provides direct supervision of personnel approving change controls, protocols/reports and investigations in support validation and automation teams.
Provides direct supervision of personnel reviewing manufacturing maintenance, calibration and scheduling programs for preventive maintenance and calibrations.
Provides supervision of personnel managing the quality approval of all technical transfer documentation, including PPQ, PD, FFR, MBR, Formula Set and system Master Data
Interfaces in clinical and commercial tech transfer meetings, including with stakeholders from OE, MT, MST, PD, CMC, QPL and relevant organizations supporting transfer to manufacturing areas.
Accountable to tracking and managing risks and decisions coming out of technical transfer sub-teams and coordinating resolution with Quality Tech Transfer Lead and QA AD.
Makes decisions and communicates on minor tech transfer decisions and risks. Keeps track of tech transfer milestones for resource allocation
May represent quality in Tech Transfer Governance Meetings
Represents quality in project meetings
Supports approval of tech transfer driven risk assessments and updates, coordinating closely with field quality operations
Collaborates with other functional area managers in planning and scheduling of resources.
Performs review and approval of site and department SOPs
Develop and manage the training curriculum of direct reports as it relates to the execution of department related processes.
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 with a constant display of the BMS behaviors.
Provides direct supervision of personnel approving change controls, protocols/reports and investigations
Supports and approves complex operational investigations

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.