Director, Clinical Audit Strategy

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Job Description:

Johnson & Johnson is currently recruiting for Director QA Clinical Audit Strategy within in the JJIM R&D Quality organization! This position can be located in the US (Titusville NJ or Springhouse PA) Belgium (Beerse) United Kingdom (High Wycombe) or Switzerland (Allschwil).

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-060968
EMEA Requisition#

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Position Summary:

The Director QA Clinical Audit Strategy will be a key member of the R&D Quality (RDQ) Clinical QA leadership. This role will lead a global team of Clinical QA Program Leads and drive cross-functional partnerships in a highly matrixed organization. Main responsibilities will include but are not limited to:

• Drives and delivers audit strategies/capabilities across all GCP audit types (including Clinical Investigator Site Audits Clinical Program Audits System Audits ESP Audits and LOC Audits) ensuring implementation of risk-based methodologies and innovative tools consistently across programs.
• Drives close partnership between Clinical QA audit strategy and execution teams to foster collaboration ensure seamless E2E clinical audit process and strong connectivity of all Clinical QA audit data to enhance the overall value of Clinical QA.
• Drives cross-domain and cross-functional partnerships to ensure Clinical QA audit strategies continue to evolve in line with emerging needs and add value to the overall Quality and Compliance of JJIM clinical programs.
• Interfaces with Quality partners and business partners specifically supporting TA Clinical Programs to ensure audit strategies are properly developed and effectively executed.
• Conducts GCP audits & support GxP Audits including resolution of CAPAs when applicable.
• Serve as the primary contact for Clinical QA related to HA Inspections including inspection readiness and coordinating with other functions as needed.

• Leads and develops a team of direct reports; C coaches and mentors other Clinical QA team members to support talent development and training foster effective leadership skills and competencies to shape a collaborative and efficient auditor organization that meets current and future business needs.

• Takes an active role in and leads projects and teams in key project initiatives across the organization or company.

Qualifications:

Education:

A minimum of a Bachelor of Science (BSc) degree is required with a focus in science life science or pharmaceutical science is required. An advanced degree (M.D Ph.D MSc or Pharm D) would be desirable.

Required:

• Deep knowledge and understanding of the drug development process GxP functional compliance regulations (national and international) sound research and development practices scientific terminology company quality assurance procedures and policies and quality evaluation techniques.
• Excellent communication organization investigation and negotiation skills and be diplomatic
• Advanced problem-solving skills.
• Advanced strategic thinking related to new and emerging technologies and analytics and ability to identify opportunities where creative capabilities may be applied within QA audit processes.
• Track record of leading global strategic initiatives in the R&D Quality and Compliance areas.
• Experience of leading and advancing a global team of direct reports.
• A minimum of 12 years relevant work experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP regulated discipline).
• This position may require up to 20% domestic & international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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