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Director Quality Assurance, Cork

Ireland, Munster, Cork
Last update 2024-02-21
Expires 2024-02-20
ID #2013663589
Free
Director Quality Assurance, Cork
Ireland, Munster, Cork,
Modified February 1, 2024

Description

Job Description - Director Quality Assurance (2406165647 W) Director Quality Assurance - 2406165647 W Description Janssen Sciences Ireland is recruiting for a Director, Quality Assurance, located in Cork, Ireland This position is responsible for leading all Quality Assurance related programs and activities to support JSI site.

These functions and activities include Quality Assurance and product release activities.

Ensures that products align with applicable standards and have been manufactured and released according to c GMP.

KEY RESPONSIBILITIES: Responsible for appropriately staffing and developing the Quality assurance organization to meet business needs and succession plans.

Organization and efficient management of Quality Assurance and in accordance with internal/external regulations, policies, and international regulatory requirements.

Partners J&J Quality and Headquarters to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.

Functions in a leadership role on the Site Quality Leadership Team.

Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement.

Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release.

This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety, quality and regulatory policies and guidelines.

Leader of QA organisation in technical and personnel aspects, definition of performance goals and employee’s appraisals.

Ensure inspection readiness and lead HA, regulatory compliance, and customer audits.

Assures that appropriate metrics/targets are established and met.

Provide leadership to direct reports through: Developing and championing an organizational culture that promotes behaviours that lead to outstanding business performance and organizational excellence.

Engages in proactive relationships with the local/regional/national regulatory authority.

Encourages, supports, and advises initiatives and programs that lead to improved quality and regulatory compliance.

Leads and guides staff and those involved in quality activities to achieve the best results.

Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.

Qualifications Advanced degree required or equivalent experience in a scientific or engineering field.

EXPERIENCE AND SKILLS: Required: 7-15 years’ experience in a significant leadership position within the pharmaceutical industry.

Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.

Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Shown success in leading in a global organization.

PREFERRED: Experience on a site manufacturing licence as Qualified Person OTHER: Gives strategic direction to the Quality groups in the execution of their duties.

Coordinates the activities of the groups within quality to create a collaborative approach to goals and tasks.

Through personal expertise, leadership, and dedication, provides direction to the site in the development of a culture of quality and compliance.

Participates in the overall collective leadership by the senior management team at the site.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com Primary Location Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.and Equal Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.

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You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, Inc.with any questions or search this site for more information.

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Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Director quality assurance

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