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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: Manager, Clinical Quality Services
Location: Bridgewater, MA
Department: Clinical Quality
Shift: First Shift
Reporting To: Director of Clinical Quality Services
Supervisory: Yes
In support of and under the direction of the Director of Clinical Quality Services, the Manager, Quality Clinical 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 that we deliver a quality product / service on time. This role will help to ensure project success through active leadership to provide PCI a competitive advantage in long-term quality customer management.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
In support of and under the direction of the Director of Clinical Quality Services, supervise, empower, coach, develop & retain a team of qualified individuals through employee development, performance management, planning and recognition.
Facilitate daily quality team performance to ensure all goals and objectives are met and to help build a culture of safety, quality, performance, customer service, and continuous improvement.
Provide support for customer audits, visits and conference calls. Work with the PCI-Boston Clinical Customer Focused team to help conduct deviation investigations and corrective actions. Assist with investigations and corrective action(s) to address customer complaints, CAPAs, NMR issues, etc.
Manage, coordinate and report on the status and completion of all calibration activities performed on behalf of PCI-Boston’s IM&TE assets (Inspection, Measuring & Test Equipment). Manage the investigation(s) 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. This includes periodic revalidation activities, temperature mapping and initial qualification activities associated with new installations of equipment, i.e., freezers, LN2 units, etc. Manage the change control process for these activities.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
IF YOU ARE A RESIDENT OF MASSACHUSETTS OR APPLYING FOR A JOB IN MASSACHUSETTS PLEASE READ:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
