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 Role
- The role will assume responsibility for the consistent delivery of quality compliance across the site and support in the raising and closing of events and deviations.
- The Training & Compliance Manager will also lead a training team, including the Technical Writers, that will be responsible for ensuring that all operator training is up to date and On The Job Training is delivered effectively, consistently and on time across the shifts.
- The role requires a proactive drive towards continuous improvement and efficiencies while ensuring customer expectations are met on a consistent basis.
Key Responsibilities:
- Ensure compliance with relevant safety and cGMP regulations and adherence to Company policies across all production activities, fostering a culture of safety, compliance and efficiency.
- Oversee production’s Quality metrics and support the shifts and the Production leaders in the conduct of A3s, the raising and closing of events, investigations and deviations as required.
- Support Production leaders in the investigations of events and complaints.
- Partner with Quality and CI teams to analyse training effectiveness through performance metrics, feedback, and audit results.
- Analyse the trending of complaints across production and monitor the effectiveness of CAPAs.
- Prepare reports for leadership on training completion rates, regulatory compliance status, operational readiness, and areas for improvement.
- Support in the establishment and utilisation of metrics to drive improvement activity and ensure that decisions are based on accurate data and measurement trends.
- Develop & review On the Job Training (OTJT) programmes.
- Evaluate effectiveness of OTJT programmes with production metrics and manage improvements, as necessary.
- Drive 100% training compliance in Mastercontrol across production.
- Lead the production training team and manage a process that ensures consistent delivery of OTJT across production.
- Be the principal production point of contact for all internal and external audits.
- Collaborate with the Continuous Improvement team and Department Managers to deliver operational excellence within PCI Ireland focusing on the production function.
- Work with the NPI / Validation functions as required to ensure projects are completed on schedule.
- Working with the Production leaders to identify resourcing and training deficits and develop and implement a plan to correct in a timely and appropriate manner, including the utilisation of the Technical Writers for the updating of SOPs.
- Manage teams in the absence of Production leadership and Operations Director.
- Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
- Bachelor’s Degree or Diploma in Quality, Compliance, Training & Development, business, logistics or a related area. May substitute experience in lieu of educational requirements.
- Minimum of 4 years’ experience in a compliance / operations-based role.
- Relevant regulatory experience preferably within a pharmaceutical environment.
- Solid understanding of risk and compliance principles and frameworks.
- Proficiency in creating and delivering training programs on compliance topics.
- In-depth knowledge of FDA, GMP, GDP, HACCP, hazardous materials compliance, SOPs, and operational standards.
- Strong commercial acumen and ability to understand the impact of regulatory changes on the business.
- Strong organizational, communication, and leadership skills.
- Ability to work cross-functionally and influence stakeholders at all levels.
- Detail-oriented with a proactive approach to compliance risk management and operational excellence.
- High level of integrity.
- Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
Desirable:
- A formal qualification in Training & Development or Compliance.
- Familiarity with audit procedures and regulatory inspections.
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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.
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