Quality Systems and Compliance Associate Director

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Quality Systems and Compliance Associate Director

Location:

Dublin, IE

Contract Type: Regular Full-Time

Area: Quality

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

Reporting to the Technical Director, the Quality Systems and
Compliance Associate Director is responsible for management of the Quality Systems and Compliance Department.Responsibilities include managing of Change Control system, Deviation
and CAPA system, Supplier Qualification Process and Supplier Complaints, Quality SAP process, oversight of Quality Compliance and other activities related to QMS. Contribution to the continuous improvement of the Quality Management System is required.Other additional duties may be assigned by the Technical Director fromtime to time if required.

What you will be doing

- Lead implementation of value-added Quality Management System (QMS) improvements in collaboration with global
stakeholders to achieve the company's strategic Quality priorities.
- Provide strategic and tactical direction for Quality Systems design and maintenance.
- Manage key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control,
Labeling Artwork Approval, Technical Agreements, Supplier Management, Material Qualifcation, and Site Master File.
- Measure and report site performance on key indicators of these quality systems through metrics.
- Ensure quality system performance is appropriately and well communicated throughout site. Provide guidance and assessments on other site Quality Systems.
- Ensure site compliance with HPRA, U.S. Food and Drug Administration and other regulatory authority regulations, as
appropriate.
- Develop and sustain a culture of constant site readiness for site inspections. Identify industry trends and implementation strategies to keep the site ahead of the compliance curve
- Identify, assess, communicate, manage, and mitigate quality system risks.
- Lead Change Control Review Boards (CCRBs) and drive CCRB improvement and standardization globally.
- Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
- Represent QS&C function on business development and integration projects.
- Create and update procedural documentation and work instructions with accuracy and clarity.
- Support GMP and GDP audits and inspections.
- Develop a support/service mentality in Quality staff, partnering with local site departments.
- Serve as a key participant in site regulatory agency inspections.
- Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines.
- Development management and coordination of Data Integritystandards and procedures.
- Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations.
- This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counselling,
building and executing development plans, and providing career counselling for career progression.
- Maintain accountability for own team's performance metrics that support the annual operating plan and site strategic plan
objectives.
- Provide hands on training, support, and coaching to reports.
- Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting Incidents and accidents to site leadership.

What you bring to the role

- Competence in Microsoft packages specifically Word, Excel and PowerPoint.
- Ability to work proactively on own initiative.
- Excellent technical writing and analytical skills.
- Flexibility.
- Results orientated.
- Process improvement and procedure writing expertise.
- Experience of conducting audits.
- Demonstrated project management experience in leading crossfunctional teams.
- Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
- Knowledge of global GxP requirements for quality systems, drugs, and devices.
- Direct prior experience with planning, ownership, and quality oversight of change controls, deviations and CAPAs.
- Excellent written and verbal skills and strong interpersonal skills
- Experience managing global projects with team members in multiple locations
- Facility start-up experience.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an
accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem
solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- Previous experience in managing/supervising
- Previous experience in facilitating of health authorities' audits
- 10 + years' experience in Quality Systems within the pharmaceutical industry.
- Bachelor's degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
- Proven ability to work in a high-paced, goaldriven organisation and consistently achieve targets

Our Benefits Include:

- Highly competitive salary
- Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
- 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 eg. 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

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