Associate Director Quality Operations

2 weeks ago

Dublin, Dublin City, Ireland Grifols, S.A Full time

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

Directs the activities, administration, and control of various Quality Assurance activities for biological products manufactured by Grifols Worldwide Operations (GWWO) and/or other Grifols affiliates. Provides quality direction to ensure timely product release and that each product meets the quality standards of safety and efficacy to comply with its intended purpose. Establishes policies, practices, procedures, and specifications applicable to the manufacture and release of biological products. Provides technical direction and general leadership and may serve as a liaison with local and international regulatory agencies.

KEY RESPONSIBILITIES:

  • Support for Quality Assurance Department.
  • Directs quality assurance business unit functions for GWWO and/or other Grifols affiliates.
  • Establishes Quality Operations policies, systems, procedures, and specifications for raw materials, in-process materials, and finished products in accordance with high standards.
  • Ensures compliance with state-of-the-art standards, current GMP regulations (domestic and international), and corporate requirements.
  • Directs the development of specifications and methods to assure the approval of IND/NDA/PLAs for products researched for GWWO and that R&D lots are manufactured according to cGMP.
  • Ensures that clinical supplies meet regulatory requirements for Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  • Participates in the technical review process and approves all new or modified products before submitting for HPRA approval and/or release to the market.
  • Approves all Quality Assurance and production procedures to ensure conformity to current cGMP regulations.
  • Coordinates activities of various departments for product recalls if necessary.
  • May provide technical direction and act as a liaison to other Grifols Inc. locations on Quality related issues.
  • Recommends removal of unsatisfactory products from the market and ensures effectiveness of return.
  • Represents Technical Director in delegated responsibilities.
  • Assumes responsibility for GWWO products in the absence of the Technical Director.
  • Regularly interacts with cross-functional senior management and builds business partnerships. Coordinates resources for ongoing projects across business groups and addresses cross-team issues.
  • Manages one or multiple departments through subordinate managers with budgetary and business objective accountability.
  • Sets goals and budgets consistent with company financial practices and standards. Develops cost/benefit analyses for major expenditures. Leads company-wide projects with significant financial implications.

PERSON SPECIFICATION:

  • Demonstrated strong leadership skills and managerial experience in a regulated environment.
  • Knowledgeable in scientific disciplines to direct staff of several Ph.D. level personnel in problem-solving.
  • Familiar with government regulations worldwide to assure the development of Quality systems conforming to the country and a thorough understanding of Good Manufacturing Practices required for clinical supplies release.
  • Excellent strategic and tactical decision-maker.
  • Aligns with corporate strategic vision and provides leadership. Encourages informed risk-taking and acts as a catalyst for innovation.
  • Experience in using SAP.
  • Strong understanding of pharmaceutical quality processes and systems, manufacturing processes, and other support/control systems.
  • Experience in Statistical Process Control (SPC).

QUALIFICATIONS:

  • MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status.

KEY COMPETENCIES:

  • Strong understanding of biology, chemistry, and microbiology scientific disciplines.
  • Excellent people skills to influence, motivate, teach, and encourage direct staff and peers.
  • Excellent delegation skills to oversee and lead the quality assurance group.
  • Solid problem-solving skills.
  • Excellent technical writing and analytical skills.
  • Excellent presentation skills.
  • Competence in Microsoft packages specifically Word, Excel, and PowerPoint.
  • Ability to work proactively on own initiative.
  • Results and detail-oriented.
  • Process improvement and procedure writing expertise.
  • Demonstrated project management experience in leading cross-functional teams.
  • Flexible and able to adapt quickly to change in a fast-paced environment.
  • Willing to travel as required.

OUR BENEFITS INCLUDE:

  • Highly competitive salary.
  • Group pension scheme - Contribution rates are 5% employer and 5% employee.
  • Private Medical Insurance for the employee.
  • Ongoing opportunities for career development in a rapidly expanding work environment.
  • Succession planning and internal promotions.
  • Wellness activities - Social activities e.g., Padel, Summer Events.

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

  • Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
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