Associate Director Regulatory Compliance

PCI IRL Millmount Healthcare Ltd; Ireland; On-site; EUR 90,000 - 130,000; Full time

Job summary

PCI Pharma Services is seeking a senior Regulatory Compliance leader to drive the EU/UK regulatory program from the Ireland, UK and Berlin sites. You will oversee QP release, manage cross-site compliance, and lead the team to ensure alignment with EU/HPRA and global standards.

The role requires SME in Sterile/ATMP, Annex 16, and strong leadership. Occasional travel to PCI sites across Europe will be expected as the business grows.

Qualifications

• Bachelor’s degree in science, engineering or related discipline.
• 5–10 years’ experience in a quality management role in the pharma industry.
• SME in Sterile, ATMP and Annex 16 Compliance.
• EU GMP knowledge (HPRA/FDA).
• Willingness to travel between PCI EU Pharma Sites.

Responsibilities

• Own and lead Regulatory Compliance activities for PCI EU/UK sites.
• Certify QP for Clinical/Commercial activities as required.
• Oversee regulatory changes and maintain compliance with EU/UK regulations.
• Coordinate QP supply chain management, audits, and quality agreements.
• Develop and monitor the department budget and resources.
• Lead the Regulatory Compliance Team across Ireland, UK, and Berlin.

Skills

Sterile/ATMP expertise

Annex 16 compliance

EU GMP knowledge (HPRA/FDA)

Leadership and coaching

Regulatory change oversight

Budget management

Travel flexibility

Quality management

Strategic planning

Education

Bachelor’s degree in science/engineering/related discipline

Tools

Master Control system

Job description

Summary of Role

Act as a key member of the Site Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability, coaching, strategy and development of the Regulatory Compliance team.

• Lead the implementation and execution tasks supporting right first time QP release
• QP with broad range of Sterile/ATMP experience
• Maintain oversight of regulatory change
• Maintain regulatory compliance with HPRA and EU requirements
• Lead/Manage the Regulatory Compliance Team across EU locations Ireland, UK, & Berlin.

The regulatory compliance team is responsible for the execution of tasks relating to the introduction and maintenance of products within the Clinical Quality Assurance department in PCI.

Key Responsibilities

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department. Full ownership and accountability for the Management of Regulatory Compliance for PCI EU / UK site(s) in line with company strategy and within regulatory requirements. Main point of Contact for all Regulatory Compliance Tier 3 escalations from Customers Ensuring adequately resourced Regulatory Compliance Department with clear roles and responsibilities defined. Develop and monitor the annual budget for the department. All clinical Regulatory Compliance activities for PCI Ireland/UK fall under the scope of this role Once listed on the appropriate licences, act as a Qualified Person for Batch Review and release in line with appropriate EU guidance and regulations. Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company Routine Operations: Certifying QP for Clinical/Commercial activities as required to support sites To ensure that there is a system including resources, management structure and accountability in place for the following: Be a Leader supporting Team to make decisions and driving leadership at all levels of Regulatory Compliance Define the strategy and design a functional structure for Reg Compliance working with Managers to ensure Compliance and Customer needs are met. Management of the oversight/design of Products Specification File (PSF) for Clinical supply chain Developing Quality Systems & Compliance to support the maintenance and release of third clinical supply chains at PCI. Design and ensuring maintenance of the clinical approved products and supplier lists. Ensuring Maintenance of Approved CMO list for Clinical Supply Chain Oversight of the maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation. Attend on going set up for new projects and provide quality support and awareness of EU/UK regulations to clients support clients in management of regulatory changes Ensure on-going compliance and support with customer, regulatory and internal requirements. Co-ordinate QP Supply chain Management Programme, including CMO audits, preparation and review of quality technical agreements, CMO/Internal PCI Site qualification and performance for third party suppliers. Coordinate the request, manage, preparation of Quality documents (QP Declarations, QP to QP, QTA) for review and approval by third party QP/ third party quality contacts at PCI. Ensure QP Confirmation is correctly used in line with EU Annex 16. Review, approve, track third party product quality or regulatory impacting notifications / support wider implications Review of Deviations, Corrective Action Requests, and Non-Conformance reports raised as required in a timely manner and ensure that issues are communicated to management. Lead/Input Technical Sterile/ATMP expertise for notifications that may impact QP Certification across EU Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities. Build a strong working relationship with other departments, including operations, project management and Qualified Persons/Quality Assurance as a whole. Ensure regulatory compliance personnel are trained to make decisions at the correct level supporting Quality principles throughout the business Tracking and monitoring of documentation throughput times. Ensuring metrics are in place, are measured and maintained and are in line with Company targets. To act as the main focal point for regulatory compliance related matters at all PCI Clinical Ireland / UK facilities.

Knowledge / Skills & Experience Essential

• Bachelor’s degree in science, Engineering, Technology or a related discipline.
• SME in Sterile, ATMP and Annex 16 Compliance Experience working within a Pharmaceutical Environment.
• Industry knowledge of the requirements of EU GMP (HPRA/FDA).
• Strong organisational / time management skills.
• Effective interpersonal communications and management skills.
• Flexibility to travel between all PCI EU Pharma Sites.
• High motivation, flexibility and the ability to work on own initiative.
• At least 5-10 years’ experience in a quality management role in the Pharma industry.

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future