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 independe

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