Supervisor, Clinical Quality D

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. Summary of Objective: Clinical Quality Supervisor is responsible for supervising the daily operations of the Clinical Quality Department including but not limited to: In-Process/FG Inspection, and when required Receiving Inspection. This will be achieved by providing resolution to quality issues/deviations, training and mentoring a high performing staff and determining and maintaining high quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures and customer requirements. 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 according to the needs of the business. Accountable for the overall supervision, resource allocation and workload planning for In-Process/FG Inspection, Distribution and Returns Inspection, and Clinical Quality Label Room Inspection teams. Oversees/directs Quality Ops activities, responsible for the direct supervision of a team of quality inspectors; ensures their personnel development by coaching to high performance goals and PCI standards. Responsible for overseeing Quality improvement processes in all Clinical Quality Inspection functional areas; includes training, mentoring and the development of all direct reports equitably. Responsible for resolving quality related issues within all Clinical departments by utilizing all applicable SOP’s and written guidance; must be able to make “Risk Based” decisions impacting product quality standards that will ensure a collaborative balance between quality needs verses operational requirements. Organizes and directs department and team meetings to include but not limited to) Clinical Batch Record improvement meetings. Generates and presents Quality Ops metrics and key performance indicators for the Quality Operations Team; specifically to Senior PCI Management teams and internal team members as appropriately needed. Reviews and interprets customer standards, procedures, and specifications relative to records, forms, and Batch Records; includes Standard Operating Procedures (SOP’s) Work Instructions (WI’s) and Job Aid’s. Reviews and approves internal and Customer-based Batch Record specs required for production packaging. Provides daily feedback and collaborates with Operations regarding Quality and Business related items. Responsible for Internal and External “Right First Time” documentation compliance across Functional areas; hosts weekly meetings with Quality and Ops leadership to discuss errors and preventative measures. Studies and standardizes’ departmental work practices to improve quality and ensure team compliance. Promotes continuity between quality shifts to ease into effective shift transition; presents relevant quality notes such as, but not limited to: quality events, staffing issues, and upper management messaging. Responsible for initiating all Quality Ops related events and documenting in QMS; determines Root Cause/Corrective Actions, and assists with investigation response to Senior Supervisor or Manager. Responsible for gather information and entering NONC’s (Non-Conforming Material Reports) in the QMS. Responsible for communicating employee disciplinary issues to HR and Quality Management; seeks recommendations on actions required before counseling and administering documentation to subordinates. Responsible for maintaining and monitoring quality testing equipment as need needed for the department. This position may require overtime and/or weekend work. 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: - Associate's Degree in a related field and/or 1-3 years related experience and/or training. Basic Mathematical Skills Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. High Standard of Report Writing Preferred: Ability to identify and resolve problems in a timely manner. Ability to display a willingness to make decisions. Ability to hold oneself in a professional manner. Ability to display excellent time management skills. The hiring rate for this position is $62,960 -$70,830 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). #LI-DT1 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.