Sr Manager QA Technical Operations

Bristol-Myers Squibb; Harvard (MA); On-site; USD 130,000 - 158,000; Full time

Benefits offered by this job

Health Coverage

401(k) plan

Disability Insurance

Life Insurance

Travel protection

Legal support

Paid Time Off

Summer hours

Volunteer days

Job summary

Bristol Myers Squibb in Devens, MA seeks a Senior Manager QA Technical Operations to lead a team overseeing Change Controls, Validation, Tech Transfer and QA for Automation. You will ensure compliance with US/EU cGMP and coordinate audits with internal stakeholders.

The ideal candidate has a BS in science/engineering and 8+ years in biopharma operations, with 2+ years in people management, and a track record building high-performance teams within biotech manufacturing environments.

Qualifications

• B.S. in science, engineering, biochemistry or related discipline.
• 8+ years’ experience in biopharmaceutical operations with 2 years of management desirable.
• Experience building and growing an organization into a high-performance team.
• Strong background in quality assurance operations and cGMP compliance for commercial biologics manufacturing.
• Knowledge of biotech bulk and finished product manufacturing and analytical testing.

Responsibilities

• Provides direct supervision of personnel approving change controls, protocols/reports and investigations in support validation and automation teams.
• Oversees maintenance scheduling programs for preventive maintenance and calibrations.
• Represents quality in tech transfer governance meetings and in project meetings with stakeholders.
• Supports and approves tech transfer driven risk assessments and updates; coordinates with field quality operations.
• Develops and manages training curriculum for direct reports related to department processes.

Skills

Quality assurance

Leadership

Regulatory knowledge

Risk management

Cross-functional collaboration

Education

B.S. in science or engineering

Tools

SAP

LIMS

Maximo

Syncade

DeltaV

Veeva Vault

Job description

Working with Us Challenging. 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. 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: 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.

Major Duties and 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

Knowledge and Skill

• 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.

Qualifications

• 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.

Compensation Overview

Compensation Overview: Devens - MA - US: $130,020 - $157,559

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

Our benefits include: 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.

Unikely Interesting Work, Life-changing Careers

Unikely Interesting Work, Life-changing Careers With 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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Visitors: 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: https://careers.bms.com/california-residents/.

R1605495 : Sr Manager QA Technical Operations Data Privacy Link

R1605495 : Sr Manager QA Technical Operations Data Privacy Link

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