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<< LISTINGS

Posted on: July 10th, 2024
Job Type: Pharma Manufacturer

Job Description:
Axtria is a global provider of cloud software and data analytics to the Life Sciences industry. We help Life Sciences companies transform the product commercialization journey to drive sales growth and improve patient healthcare outcomes. We are acutely aware that our work impacts millions of patients and lead passionately to improve their lives.

As the Executive Director of Global Clinical Quality Assurance, this position will lead our global quality assurance strategy to ensure compliance with Good Clinical Practice (GCP) and regulatory standards. This role requires substantial experience with US and international audits and inspections, a deep understanding of GCP, and the ability to maintain the highest quality standards in clinical research.

This position reports to the VP, Global Quality Assurance and can be hybrid based out of the New Providence, NJ office.

Job Responsibilities:

• Global Quality Oversight: Develop and implement global quality assurance policies and procedures that comply with GCP and regulatory requirements across different regions.
• Audit and Inspection Management: Lead and manage comprehensive audit programs, including both routine and for-cause audits, to ensure adherence to GCP and regulatory compliance. Oversee preparation and response strategies for both US and ex-US regulatory inspections.
• Regulatory Strategy and Compliance: Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans. Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices.
• Stakeholder Engagement: Serve as the primary quality assurance liaison with regulatory authorities, partners, and internal stakeholders. Ensure transparent communication and collaboration on quality-related matters.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or related field. An advanced degree (MS or PhD) is preferred.
• At least 20 years of experience in clinical quality assurance within a global organization, including extensive GCP-focused work and managing international audits and inspections. Experience in a small biotechnology company is also preferred.
• Certification in Quality Assurance such as CQA or RQAP-GCP preferred.
• Experience with PV Quality preferred.
• Experience in hematology/oncology trials preferred.
• Extensive knowledge of ICH GCP and relevant global regulations and guidelines with the ability to apply the principles.
• Expert knowledge of GCP, FDA, EMA, and other international regulatory standards.
• Experience interacting with inspectors and cross-functional, global teams is required.
• Experience in working with an outsourced model for clinical trials is preferred.
• Exceptional leadership and organizational skills.
• Strong analytical skills and a methodical approach to problem resolution.
• Excellent communication skills, capable of effectively presenting and discussing complex issues to influence outcomes.
• Strong project management skills and demonstrated ability to look at the big picture when making decisions and accounting for what may be in the best interest of ADCT.
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently solve problems and facilitate resolution of issues.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Ability to travel globally 15% as needed to office locations and for business meetings.

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

Attention: Search firms/Third-party recruitment agencies

The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role. Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited. Unsolicited résumés sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited résumés. Please send all emails and requests to This email address is being protected from spambots. You need JavaScript enabled to view it..