Key Role Specific Requirements:
- Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
- Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (eg Continuous Improvement) and supporting new product development.
- Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
- Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
- Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
- Acts as the primary contact with regulatory agencies for all communication for the site.
- Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
- Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
- Responsible for final product release to customer.
- Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
- Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
- Organizes and hosts facility audits by customers, HPRA including responding to corrective actions and /or observations as required.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role:
- ACCOUNTABILITY/ EXECUTION – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
- ADAPTABILITY/ CHANGE AGILITY – Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose, and embraces change. Strives for continuous improvement.
- AMBIGUITY– The ability to be comfortable with change and uncertainty. The ability to deal with fuzzy problems with limited data and with no clear solutions. The ability to juggle several projects or to not bring closure to one project because of business changing needs.
- INTEGRITY/ PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
- JUDGEMENT – is the ability to make considered decisions or come to a sensible conclusion.
- Ten years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role
- Practical experience acting as Qualified Person releasing product into the Irish and European Markets
- BSC degree in science or related field
- Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
- Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
- MS degree or MBA as asset
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.