Manager, Clinical Quality Services

About the role

In support of and under the direction of the Director of Clinical Quality Services, the Manager, Clinical Quality Services helps to plan, direct, and coordinate the Quality activities of a designated Clinical Customer Focused Team to ensure that the goals and objectives of the team are accomplished within the prescribed time frames and within budget.

This role will supervise, empower, coach, develop, and help to retain a team of qualified individuals including Quality Specialist(s) and Quality Inspector(s) while partnering with the PCI-Boston Clinical Project Management team(s) to ensure delivery of a quality product/service on time. The role ensures project success through active leadership, providing PCI a competitive advantage in long-term quality customer management.

Responsibilities

• Supervise, empower, coach, develop, and retain a team of qualified individuals through employee development, performance management, planning, and recognition.
• Help establish quality team and individual goals and objectives aligned with Clinical Customer Focused Team goals and customer requirements.
• Ensure strong alignment and coordination with other PCI business units and functional groups.
• Collaborate on “best practices” with other Clinical Quality Managers and leadership.
• Facilitate daily quality team performance to ensure all goals and objectives are met and help build a culture of safety, quality, performance, customer service, and continuous improvement.
• Manage the training and development of the quality team, including cross-training initiatives and onboarding of new employees.
• Provide support for customer audits, visits, and conference calls.
• Work with the PCI-Boston Clinical Customer Focused team to conduct deviation investigations and corrective actions.
• Assist with investigations and corrective actions to address customer complaints, CAPAs, NMR issues, etc.
• Collaborate with team members to manage team performance metrics and customer scorecards.
• Collaborate with Business Development and Project Management teams to coordinate and facilitate customer Quarterly Business Reviews (QBRs).
• Manage, coordinate, and report on the status and completion of all corrective and preventive maintenance activities for PCI-Boston assets.
• Serve as the primary point of contact for PCI-Boston’s maintenance program and process.
• Manage, coordinate, and report on the status and completion of all calibration activities for PCI-Boston’s IM&TE assets (Inspection, Measuring & Test Equipment).
• Manage investigations associated with any instances of OOS (Out of Specification) results identified during calibration activities.
• Manage, coordinate, and report on the status and completion of all qualification and validation activities at PCI-Boston as per the site Master Validation Plan and related SOPs and WIs, including periodic revalidation, temperature mapping, and initial qualification activities for new equipment installations (e.g., freezers, LN2 units).
• Manage the change control process for these activities.
• Adhere to PCI and cGMP policies, procedures, rules, and regulations.
• Perform other duties as assigned by the site Director of Clinical Quality Services.
• Provide day-to-day supervision of team staff under the direction of the site Director of Clinical Quality Services.

This position may require overtime and/or weekend work. Attendance is an essential function of this position.

Requirements

• Bachelor’s Degree in a related field and/or 3-5 years of related experience and/or training.
• College-level mathematical skills.
• Advanced computer skills, including the ability to perform complex computer tasks and operate various programs.
• Full professional proficiency in speaking, reading, and writing English.
• High reasoning ability to solve practical problems and deal with concrete variables in situations with limited standardization.
• Ability to interpret a variety of instructions provided in different forms.
• Working knowledge of calibration, preventive maintenance, and validation cGMP-compliant processes and programs.

Preferred Qualifications

• Experience with project management.

Pay

The hiring rate for this position is $95,360–$107,280 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

PCI offers full-time employees a competitive benefits package that includes:

• Paid time off.
• Health insurance coverage (including dental and vision).
• Flexible spending account.
• 401(k) retirement plan.