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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 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. 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. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Summit West - NJ - US: $125,740 - $152,368
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.
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 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 adastaffingsupport@bms.com. 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.
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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R1604142 : Senior Manager, ECQ Delivery