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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.  The role of the Associate Director of Regulatory Compliance is to:

·         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.

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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.

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.