Role And Responsibilities
- Serve as the designated Responsible Person, ensuring full compliance with ProLuca WDA requirements and all related GxP and Medical Device activities within the On Demand Ireland business unit.
- Act as DRP on the clients wholesale WDA
- Ensure all tasks are executed in alignment with the clients policies and procedures.
- Lead and coordinate regulatory and client inspections as necessary.
- Manage and guide the Quality team to achieve strategic and operational objectives.
- Design, implement, and maintain a Quality Management System (QMS) that meets the compliance standards of a Marketing Authorisation Holder (MAH).
- Ensure adherence to quality standards as defined by the QMS.
- Train and support staff in new quality initiatives, promoting understanding and consistent implementation across the site.
- Maintain and update regulatory standards and procedures in line with applicable regulations, guidelines, and specifications.
- Identify opportunities for system improvements or technical issues, collaborating with technical teams to develop and implement effective solutions.
- Oversee outsourced activities for the On Demand business, ensuring robust compliance processes in Pharmacovigilance (PV), Regulatory Affairs, and Advertising, with clearly defined MAH responsibilities in the QMS.
- Act as a Subject Matter Expert (SME) for the management of Exempt Medicinal Products within the On Demand business.
- Evaluate requirements and provide feedback on completeness, risk areas, and potential impacts on quality compliance.
- Collaborate with the wider On Demand Quality and Management Teams to identify and implement process improvements.
- Contribute to the development of high-quality systems that meet documented specifications, compliance standards, and business objectives.
- Lead cross-functional meetings to triage and resolve quality issues.
- Foster strong relationships with internal and external stakeholders, promoting a culture of continuous improvement.
- Prepare and maintain weekly and monthly reports/KPIs summarizing key activities and performance metrics.
- Engage in ongoing professional development and support team learning to stay current with evolving regulations and ensure timely implementation.
- Manage third-party providers and processes related to outsourced GMP activities.
- Undertake additional projects or activities as assigned by the Group Quality Director.
Qualification, Experience & Skills Required
- 3-5 years of professional experience in a regulated environment (GDP, GMP, or Unlicensed Medicines).
- Prior experience working within a commercial affiliate of a Marketing Authorisation Holder (MAH).
- Demonstrated experience in Regulatory Affairs, Pharmacovigilance, and Advertising compliance, specifically related to MAH responsibilities.
- Proven track record of participation in regulatory authority inspections.
- Experience serving as a Responsible Person (RP) or Deputy RP under a Wholesale Distribution Authorisation (WDA).
- Strong leadership capabilities with the ability to manage and develop a small team effectively.
- Excellent interpersonal and communication skills, with the ability to engage confidently across all levels of the organisation.
- Highly developed organisational, analytical, problem-solving, influencing, and management skills.
- Project management experience is advantageous.
- Proficient in standard software applications, including word processing, spreadsheets, and data analysis tools.
- Ability to thrive in a fast-paced, collaborative environment with sound decision-making and problem-solving abilities.
- Strong time management and prioritisation skills, with a focus on meeting tight and overlapping deadlines.
- Exceptional attention to detail, organisational skills, and accuracy in record-keeping.
- Capable of working independently with minimal supervision.
- Familiarity with validation methodologies.
- Commercial awareness and business acumen.
- A bachelor's degree in a science or healthcare is preferred.
Competencies
- Positive can-do attitude with a focus on action does not debate.
- Results orientated.
- Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met.
- Resolves conflict constructively and works well under pressure.
- Attention to detail.
- Strong communication and negotiation skills.
