Senior Manager, Commissioning Qualification Validation

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Description:

The Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal team members, peer-level customers, and external service providers. The incumbent supervises entry, junior, and experienced-level professionals tasked with commissioning and qualifying new equipment, facilities, and utilities, and maintaining equipment systems in a qualified/validated state according to established policies and procedures. The individual oversees multiple projects and ongoing work activities of low to moderate complexity to ensure on-time and within-budget completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work and may recommend modifications to work processes or procedures to functional management.

Shift: Mon-Fri: 8AM-5PM

Commissioning and Qualification Activities:

·       Directly manage Equipment Commissioning & Qualification equipment qualification and computerized system validation teams.

·       Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and standalone/enterprise computerized systems.

·       Define the needs, benefits, and technical strategy within the project life-cycle and overall processes.

·       Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.

·       Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.

·       Maintain departmental commissioning and qualification procedures and policies. Ensure site and project master plans comply with global policies and regulatory agency requirements.

·       Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.

·       Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.

·       Ensure compliance with Facilities Services Qualification Master Plan.

·       Oversee the site requalification activities and requalification programs.

·       Responsible for developing and managing budgets and resources for the program.

·       Create departmental metrics; understand, review, and deliver metrics to the team to determine areas for improvement.

Project Work Support:

·       Lead a larger team of up to 50 people across multiple areas, including 3 direct supervisors/manager-level personnel.

·       Interview and hire internal and/or external personnel to fill necessary roles.

·       Provide direction to internal and external team members.

·       Manage the workload of team members to ensure appropriate work-life balance.

·       Delegate, develop, and motivate direct and contract reports.

·       Set departmental and individual goals.

·       Deliver personnel performance reviews.

·       Ensure team members are appropriately trained for duties being performed.

·       Assist in the preparation of departmental operational expense and capital budgets; justify and work within approved headcount.

·       Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.

·       Ensure the team is in full compliance with local, site and global BMS policies and procedures.

·       Manage staff workload of multiple complex projects and priorities across the many different departments that the ECQ organization serves.

·       Develop an effective mechanism for communicating the current status of all laboratory systems maintained by ECQ to all affected stakeholders.

·       Communicate effectively with peers and senior management to identify needs, justifications, and evaluate alternative business solutions when appropriate.

Customer Service and Support:

·       Regularly review, prioritize and promptly respond to customer equipment qualification and support requests.

·       Provide technical support and guidance on equipment and computer systems qualification and validation issues. Interface with customers to ensure all expectations are being met.

·       Maintain a positive relationship with all members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.

·       Continually seek opportunities to increase internal client satisfaction and deepen client relationships.

Regulatory Responsibilities:

·       Ensure equipment, facilities and programs are maintained in compliance.

·       Act as departmental lead and SME in both internal and regulatory audits.

Specific Knowledge, Skills, Abilities:

·       Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

·       Expert knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

·       Ability to develop, delegate, and motivate others including direct and indirect reports.

·       Strong financial acumen.

·       Solid understanding of scheduling fundamentals, execution and cost control.

·       Advanced understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

·       Strong multi-tasking ability in conjunction with proven managing skills; ability to effectively manage multiple projects, initiatives and activities simultaneously.

·       Strong written and verbal communication skills.

·       Excellent interpersonal skills with experience working across a broad range of teams.

·       Strong presentation development and delivery skills.

·       Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business tools.

·       Working knowledge of scheduling software and systems, and inventory management systems, mainly CMMS.

·       Ability to create and analyze meaningful metrics.

·       Experience with departmental capital and expense budget forecasting and management.

Working Conditions:

·       Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.

·       Ability to sit, stand, walk and move within workspace for extended periods.

·       Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

·       Primarily an office environment. Will be required to enter laboratories or GMP process areas donning proper gowning/lab coats or PPE such as safety glasses and shoes.

·       Ability to work safely and effectively when working alone or working with others.

Education and Experience:

·       BS in Engineering or Science related discipline required.

·       Minimum of 7 years experience performing/supporting pharmaceutical application validation in a GMP environment.

·       Minimum of 7 years experience managing personnel and projects.

·       Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct face-to-face interaction and response to audit questions.

·       Thorough knowledge of cGMP in the pharmaceutical industry.

·       Advanced computer skills and demonstrated knowledge of validating computer systems used in the pharmaceutical industry.

·       Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

·       Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Summit West - NJ - US: $125,740 - $152,368


The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  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/

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If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1604142 : Senior Manager, Commissioning Qualification Validation