Associate Director, Quality Assurance Lead
2 months ago
Job Title: Associate Director, Quality Assurance
Job Summary:
Organon is seeking an experienced Associate Director, Quality Assurance to lead our In-Market Quality team in AP. The successful candidate will be responsible for ensuring compliance with global GDP and GMP regulations, as well as maintaining strong partnerships with global/regional colleagues and teams that impact Quality and Compliance.
Key Responsibilities:
- Develop and implement quality systems and processes to ensure compliance with global GDP and GMP regulations.
- Lead a team of quality professionals to ensure effective implementation of quality systems and processes.
- Collaborate with global/regional colleagues and teams to ensure alignment of AP IMQ function with global quality systems and regulations.
- Develop and implement performance management processes to monitor compliance and continuous quality improvements.
- Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications and Market Actions.
Requirements:
- Bachelor or Masters Degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent).
- Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorizatin Holders and countries in scope.
- Strong compliance mindset, excellent project management and organizations skills.
- Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments.
About Organon:
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
What We Offer:
- A competitive annualized salary range.
- Opportunities for professional growth and development.
- A collaborative and inclusive work environment.
- A comprehensive benefits package.
Relocation and Visa Sponsorship:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Organon offers flexible work arrangements to support work-life balance.
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