Sr Manager, ECQ Delivery - Summit West NJ

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS:
Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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…