Sr Manager, ECQ Delivery - Summit West NJ

Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery

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

• 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.

• 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.

• 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.

• Ensure equipment, facilities and programs are maintained in compliance.
• Act as departmental lead and SME in both internal and regulatory audits.

• Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21
  
  CFR 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…