Manager, Clinical Quality Services

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. 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 C linical Services helps to p lan, 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 Q uality Inspector(s) while partnering with the PCI-Boston Clinical Project Manage ment 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 in dividuals through employee development, performance management , planning and recognition. Help to establish quality team and individual goals and objectives that are 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 to 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 to the team. 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 action s. Assist with investigations and corrective action(s) 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 the Project Management teams to help 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 . Be the primary point of contact for PCI-Boston’s maintenance program & process. 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. Knowledge of, and a dherence to PCI and cGMP policies, procedures, rules and regulations. This position may require overtime, and / or weekend work. A ttendance to work is an essential function of this position . Performs other duties a s assigned by the site Director of Clinical Quality Services . Provides day-to-day supervision of team staff under the direction of the site Director of Clinical Quality Services. ​​ 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. Required: Bachelor’s Degree in a related field and / or 3-5 years related experience and / or training. ​ ​ College Level Mathematical Skills ​ Advanced Computer Skills : Ability to perform the most complex computer tasks and to operate various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Working knowledge of calibration, preventive maintenance and v alidation cGMP compliant processes and programs . Preferred: Experience with project management. 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.