Senior Manager, ECQ Delivery

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. 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/supportin