Associate Director Quality Operations

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. Other duties may include but are not limited to the following: 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; Provides appropriate methods and specifications for related products being researched; 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.
- Directs the establishment of Quality Operations policies, systems, procedures and specifications for raw materials, in-process materials, and finished products in accordance with high standards.
- Establishes Quality Operations systems and practices to ensure compliance with state-of-the-art standards, current GMP regulations (domestic and international) and corporate requirements.
- Directs the development of specifications, and methods established to assure the approval of IND/NDA/PLAs for products researched for GWWO and that R&D lots are manufactured according to cGMP.
- Directs Quality Operations activities within assigned area of responsibility to ensure 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 so that all phases of the plant operations conform to current cGMP regulations.
- Coordinates the activities of various departments which make appropriate recommendations, whenever recall of released product is required.
- May provide technical direction, general leadership, and act as a liaison to other Grifols Inc. locations on Quality related issues both domestic and worldwide.
- Recommends removal of unsatisfactory product from the market and ensures effectiveness of return.
- Represents Technical Director in those responsibilities delegated.
- Assumes responsibility for issues concerning GWWO products in the absence of the Technical Director.
- Regularly interacts with cross-functional senior management. Builds business partnerships with peers, customers, and vendors. Coordinates resources for ongoing projects across business groups. Addresses and resolves cross-team issues.
- Manages a single or multiple departments and may do so through subordinate managers who have budgetary and business objective accountability. Guides managers and staff to achieve tactical and strategic goals. Typically reports to a Corporate or Division Executive; may report to another Department Head.
- Sets goals and budgets consistent with company financial practices and standards. Develops cost/benefit analyses for major expenditures. Leads company-wide projects and processes that have significant financial implications. Significant spending authority includes purchase requisitions, expense reports and negotiations of multi-million-dollar transactions.

PERSON SPECIFICATION

- Must have demonstrated strong leadership skills and have managerial experience in a regulated environment.
- Must be knowledgeable in these scientific disciplines to direct staff of several Ph.D. level personnel in product or process problem-solving.
- Must be familiar with government regulations worldwide to assure the development of Quality systems conforming to the country and have a thorough understanding of Good Manufacturing Practices required for the release of clinical supplies for the medical monitors.
- Excellent strategic and tactical decision-maker. Erroneous decisions will result in critical delay(s) and may jeopardize overall business activities.
- Aligns with corporate strategic vision to provide vision, strategic direction, and leadership. Builds broad-based support and/or persuades others to influence important outcomes. Encourages informed risk-taking and acts as a catalyst for innovation within the company. Manages resources to ensure financial objectives are met, leveraging knowledge of competitive advantage and profit drivers. Works on complex issues requiring in-depth analysis of situations.
- Experience in using SAP.
- Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems.
- Experience with 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.
- Possess excellent people skills in order to influence, motivate, teach and encourage his/her direct staff as well as his/her peers to understand and accept his/her recommendations, especially with borderline issues.
- 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, 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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