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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.

Role Overview

The Senior Quality Specialist will play a critical role in ensuring compliance, oversight, and continuous improvement within the Quality department. This position is accountable for supporting Qualified Person (QP) release activities through the review of third-party product documentation, managing batch records, and driving operational excellence across the Quality Management System (QMS). Acting as a key point of contact between cross-functional teams, the Senior Quality Specialist will provide leadership, technical expertise, and mentorship to the Quality team, while maintaining the highest standards of GMP compliance.

Main Responsibilities:

Batch Review & QP Support

• Perform compliance reviews of third-party batch documentation, including review of technical documents and prepare batches for QP review/certification.
• Review and maintain the Product Specification Files to ensure accuracy and compliance.
• Manage batch review trackers, ensuring timely allocation of work across the QA team.

Quality Systems & Compliance

• Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
• Generate and report compliance metrics related to batch record review and QP preparation, ensuring continuous monitoring of QMS effectiveness.
• Support the investigation and resolution of internal and external quality issues using risk management principles.
• Author, review, and update SOPs, work instructions, and controlled documents.

Cross-Functional Collaboration

• Partner with Project Managers, QPs, and QA colleagues to drive timely resolution of batch-related issues and corrections.
• Collaborate effectively across departments (e.g., PMS, Operations, Regulatory) to ensure alignment and timely delivery of objectives.

• Inspection & Audit Support
• Act as SME for QA batch review during internal and external audits/inspections.
• Support preparation, coordination, and response activities for regulatory inspections of the Millmount facility.

• Leadership & Team Support
• Provide guidance and mentorship to Quality Specialists, supporting their development and ensuring adherence to best practices.
• Promote a culture of compliance, zero overdue actions, and Right-First-Time execution.
• Deliver QA- and GMP-related training across the site as required.

Continuous Improvement & Projects

• Support departmental and site-wide projects, initiatives, and objectives.
• Drive continuous improvement activities to strengthen compliance, efficiency, and quality performance.
• Undertake additional responsibilities aligned to the scope of the role.

Requirements:

• Science Qualification, Degree and/or relevant experience is required
• 2 to 3 years of sterilles experience in a manufacturing setting with good technical knowledge
• 7+ year’s QA Experience in pharmaceutical or medical device is required.
• Clinical experience is desirable but not essential.

Skills & Attributes:

• Strong attention to detail with a commitment to quality and compliance.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills for cross-functional collaboration.
• Leadership ability with experience guiding or mentoring others.
• Proactive team player with a continuous improvement mindset.

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.