Quality Manager and Qualified Person (College Park Dublin Ireland)
Quality Manager and Qualified Person (College Park Dublin Ireland)
JR000010625 Quality Manager and Qualified Person (College Park Dublin Ireland) (Open)
College Park, Dublin - IRL006
College Park, Dublin IRL
SUMMARY OF POSITION:
This managerial position provides leadership for onsite Quality at the College Park Manufacturing Facility, Dublin which is currently transitioning from project to sustained phase and as a result has a number of Regulatory Inspections pending. The College Park facility will manufacture API material for which the associated drug product is approved in the U.S. for certain autoimmune and inflammatory conditions.
The role includes complete signature authority, with responsibility for escalating high risk issues to management. The position also acts as a consultant to management regarding compliance issues and may lead very large projects that could cross site or divisional lines. The incumbent will coordinate compliance activities / projects with key Mallinckrodt groups.
The role will have Quality Assurance, Quality Control and QA Validation teams reporting into it.
RESPONSIBILITIES (ESSENTIAL FUNCTIONS)
- Day to day leadership for Quality aspects of the College Park facility including QC testing, QMS implementation and oversight.
- Member of the plant management team for College Park manufacturing facility wh decide and implement strategy and direction.
- Certification and Release of API lot(s) in accordance with EU & US cGMP requirements.
- Eligible to perform the Qualified Person (Q.P.) role in accordance the legislative requirements within Article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/82/EC3.
- Creation, governance and maintenance of the College Park manufacturing facility Quality Management System as defined through the Site Master File, Technical Agreements, SOPs and Eudralex – Vol.4 GMP Guidelines
- Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective
- Authorisation and Approval of Change Records, Validations and Qualifications.
- Leading the Quality unit within College Park manufacturing facility
- Communication with Competent Authorities as and when required.
- Review and approval of all Regulatory Filings.
- Approval of 3rd party Technical Agreements on behalf of Mallinckrodt where required
- Governance of all External and Internal audit programmes and plan, executing and following up on supplier site visits due to identified issues, validation/transfer activity or as routine periodic visits.
- Responsible for ongoing inspection readiness program to ensure that Quality System is managed and maintained in accordance with ICH Q7 and ICH Q10.
- Leading preparation for and hosting of regulatory inspections at College Park Manufacturing Facility in coordination with the Site Lead.
- Responsible for maintaining compliance of licenses held by Mallinckrodt pertaining to API manufactured at College Park.
- To ensure knowledge of Quality and Compliance aspects relating to the products manufactured from Acthar API manufactured at College Park is up to date.
- Management and development of members of plant Quality Team
- Identify, develop and execute project plans and timelines to achieve desired results
- Lead continuous improvement efforts for projects identified at the suppliers or within the plant.
- Participate actively on cross-functional operational and process improvement teams.
- Seek to identify and execute safety improvements and waste minimization opportunities.
- Serve as leading technical expert in one or more key quality or compliance areas.
- Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures.
- Assemble information, develop the decision and rationale for material review board (MRB) and field alert report (FAR) decisions, including follow up investigation and summary documents for both FAR and MRB.
- Support the wider Mallinckrodt Quality group as required.
- Support scorecard development, maintenance, reporting and action / project development from scorecards.
- Minimum BSc
- Qualified Person status (or 2nd year of training in process) required
- Biological / biotechnology degree an advantage
- Postgraduate qualification an advantage
- Minimum 10 years’ experience in a QA or equivalent role
- Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
- Sterile manufacturing and/or biotech experience required
- Managerial or Supervisory experience required
- Regulatory inspection experience leading a function or group
- Experience as a named QP for a licensed facility
- API manufacturing experience
- Quality Control Laboratory experience
- Experience in Biologics Manufacture a distinct advantage
- Preferred experience including, but not limited to the following:
- Application of cGMP to manufacturing and testing
- Batch release and investigations
- Change Management and CAPA
- Regulatory Affairs
- Technical Transfers
- Statistical techniques
- Electronic and paper Quality Management Systems
- Ability to manage, coach individuals and lead teams
- Ability to model and create a quality culture
- Self-motivated and self-managing.
- Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
- Critical problem-solving skills
- Demonstrated data driven decision making ability
- Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
- An understanding of the pharmaceutical industry and its unique business and social responsibilities
- Excellent facilitation and presentation skills
- Ability to plan, organize, and prioritize
- Excellent technical and compliance-based writing skills
- Ability to work with clients of diverse incumbent skill base
- Ability to manage projects involving multiple functional groups without direct reporting authority
- Strong communication and interpersonal skills
- Demonstrated leadership abilities
- Demonstrated commitment to excellent customer service
- Conflict resolution skills
- Ability to work under pressure and make effective decisions
- Requires mature judgment in problem solving situations.
- Requires negotiation skills to effectively influence others
- Ability to identify and drive continuous quality improvement - Six Sigma Black Belt or Lean Certification an advantage
- Proficiency in Word, Excel, Power Point and Access
- Experience in other computer systems (e.g. LIMs, SAP)
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.