Director, QA Internal Ops

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 Director, Quality Assurance - Internal Operations provides strategic and operational leadership for Quality Assurance functions supporting Operations, including Manufacturing, Materials Management, Facilities & Engineering. This leader ensures compliance with cGMP standards, internal procedures, and regulatory expectations while fostering a culture of quality, continuous improvement, and operational excellence.

This role is instrumental in shaping and transforming GxP programs by providing QA expertise and strategic guidance across lead product candidates and pipeline assets. The Director serves as a key member of cross-functional teams driving harmonization and optimization of quality systems and processes across all PCI GMP locations.

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.

• Provide strategic Quality oversight for internal operations, including Manufacturing, Visual Inspection, Materials Management, and Facilities & Engineering.

• Oversee QA Document Control, Training, and site-level Supplier Quality programs; ensure alignment with corporate Supplier Qualification standards.

• Develop, implement, and continuously improve quality systems, procedures, specifications, and test methods in alignment with regulatory requirements and corporate standards.

• Lead the preparation and execution of Quality Management Reviews, including analysis and presentation of key quality metrics.

• Establish and maintain strong cross-functional relationships to ensure timely resolution of quality and compliance matters.

• Drive continuous improvement by proactively identifying, assessing, and implementing enhancements to quality processes and systems.

• Serve as the QA lead on cross-functional initiatives such as technology transfer, process validation, new facility and process design, and process improvement projects.

• Perform and oversee risk assessments to ensure compliance with internal procedures and regulatory expectations.

• Review and approve controlled cGMP documentation, including SOPs, specifications, validation protocols/reports, and investigation reports.

• Ensure site readiness for regulatory inspections, client audits, and internal audits; provide direct support and leadership during these events.

• Oversee review and release of raw materials and products, ensuring timely disposition and communication to support business needs.

• Oversee management of nonconforming materials, deviations, and CAPA processes to ensure timely resolution and compliance.

• Provide QA review and approval of supplier documentation and perform or oversee supplier audits as needed.

• Foster a culture of accountability, collaboration, and continuous improvement within the QA organization.

• Lead, mentor and develop a high performing QA team; establish clear performance objectives aligned with departmental and organizational goals.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

QUALITIES -

• Ability to lead people in a dynamic, fast-paced work environment.

• Ability to lead multiple groups within internal Quality Operations.

• Honesty, integrity, respect, and courtesy with all colleagues

• Creative with the ability to work with minimal supervision and balanced with independent thinking.

• Resilient through operational and organizational change

• Demonstrated leadership, interpersonal, communication, and motivation skills.

• Well-practiced in exercising sound judgment in decision-making

• Demonstrated multitasking and organization skills.

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  PHYSICAL REQUIREMENTS & MENTAL DEMANDS -

  Frequent sitting, reading, writing, and verbal communication.

  Must be able to travel between multiple local production facilities.

  Able to translate ideas to actual concepts and processes.

  Proven ability to manage multiple projects (duties) simultaneously.

  Able to work in a highly complex environment with competing demands and priorities.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

COMMUNICATIONS & CONTACTS -

• Able to work in a highly complex environment with competing demands and priorities.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -

• Able to work in a highly complex environment with competing demands and priorities.

TRAVEL - < 10%

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.

EDUCATION -

• Bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biochemistry, Biotechnology, or related field) required.

• Advanced degree and/or ASQ certification preferred.

• Equivalent combination of education and relevant experience may be considered.

EXPERIENCE -

• Minimum 12+ years of pharmaceutical or biotechnology industry experience, including 5+ years in Quality Assurance role supporting late-stage clinical and/or commercial manufacturing.

• Minimum 5 years of leadership or management experience required.

• In-depth knowledge of cGMP requirements (US and EU), ICH guidelines, and applicable regulatory standards.

• Experience in biologics manufacturing, including drug substance and/or drug product release.

• Demonstrated effectiveness in quality systems management, compliance oversight, and operational excellence.

• Proficiency in risk management tools (e.g., FMEA, HACCP, PHA) and root cause analysis methodologies.

• Experience with quality and manufacturing electronic systems (e.g., SAP, LIMS, TrackWise, Veeva, MasterControl) preferred.

• Strong technical writing, analytical, and problem-solving skills.

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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.