Senior Manager, ECQ Delivery

About the role

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.

Responsibilities

• 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.
• Create departmental metrics; understand, review, and deliver metrics to the team to determine areas for improvement.
• 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.
• Aid in the preparation of departmental operational expense and capital budgets; justify and work within approved headcount.
• 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.

Requirements

• 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.
• Innate ability to learn new software, such as corporate intranet and enterprise business tools.

Qualifications

• 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 dealing with a diverse workforce.
• 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.
• 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.

Skills

• 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 dealing with a diverse workforce.
• 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.
• 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.

Benefits

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. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely 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.