Sr. Manager, Quality Engineering

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:

The Sr. Quality Engineer Manager will manage a team of Quality professionals to provide Quality Engineering, Quality Systems, and Calibration support for Site Quality and Operations in regards to the manufacturing and packaging of pharmaceutical and medical device products. This position is responsible for site level administrative duties of the global eQMS system for the Rockford site and also provides an in-depth investigative and technological orientation in implementing, executing and interpreting PCI's quality procedures. The Sr. Quality Engineer Manager will lead the improvement of these processes, and associated continuous quality improvement activities. This position reports to the Executive Director of Quality.

Essential Duties & Responsibilities:

• Accountable for overall management, reviewing, planning and administering of resource allocation and workload planning for the Quality Systems, Supplier Quality, Quality Engineering and Calibrations staff.

• Responsible for direct management and personnel development including training and mentoring of direct reports including Manager of North American Supplier Quality, Quality Systems Manager, Manager of Supplier Quality Engineering, Quality Engineering Sr. Supervisor, Quality Engineer(s), and Calibration Supervisor.

• Oversee and administer site risk management program

• Oversee, investigate, and approve PCI investigations including consumer complaints, trend investigations, laboratory and environmental monitoring investigations, and calibration OOS events.

• Oversee site supplier nonconformances and supplier related quality metrics

• Meet with management and supervisors to discuss likely root cause scenarios for critical investigations.

• Oversee and write/revise SOP's/WP's and submit/route change controls

• Technical evaluation of change controls including risk assessment / implementation of risk mitigation strategies.

• Oversee performance of site metrics including weekly, monthly, and quarterly report outs for quality, including leading the Quarterly Management Review meeting.

• Oversee the Document Management and Control processes.

• Apply scientific statistical analysis techniques to proactively identify trends, identify root causes and implement actions to mitigate reoccurrence.

• Statistical assessment of data to drive improvements.

• Analyze customer and business needs in determination of Quality Engineering, Supplier Quality and Calibration strategies.

• Manage the PCI North American supplier audit / quality management programs.

• Manage the PCI Rockford Calibration program including review/approval of related procedures and identification of areas for improvement in streamlining the calibration department processes.

• Manage and/or oversee the PCI Rockford Data Integrity Project including all related documentation and communication and driving the project to completion by collaborating with internal groups as well as with corporate and global partners for harmonization of data integrity initiatives.

• Lead Quality system optimization teams (i.e. lean, streamline, efficiencies, etc.)

• Work closely with other departments and sites to partner on continuous improvement projects.

• Oversee, organize, and present training on investigations especially effective root cause analysis techniques and CAPA.

• Oversee completion of customer-requested assessments including but not limited to those related to nitrosamines, animal derived materials, PFAS, food grade, allergens, etc.

• Administration or oversight of administration of ExcelSafe software including assistance in spreadsheet validation activities and system training activities

• Administration of MasterControl system for the Rockford site, including assistance with trouble-shooting the system, training, and user management activities.

• Oversee team managing approval of supplier / item relationships to ensure site only procures approved materials from approved suppliers.

• Participate in internal and customer audits and regulatory inspections.

• Oversees coordinating quality activities of team to ensure that goals and objectives of the teams are accomplished

• Develop, monitor, and control departmental budgets

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Executive Director.

Qualifications:

Required:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.

• College Level 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

• Statistical knowledge and applied experience

Preferred:

• Ability to set and achieve challenging goals.

• Ability to demonstrate attention to detail.

• Ability to exhibit sound and accurage judgment.

• Ability to follow instructions and respond to management direction.

• Ability to identify and resolve problems in a timely manner.

• Ability to display excellent time management skills.

• Ability to adapt to changing work environments.

• Ability to work independently and/or as part of a team. Ability to set and achieve challenging goals.

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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.