Associate Director, Quality Assurance Lead

3 weeks ago

Singapur, Singapore Organon Full time

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:

  • Lead the In-Market Quality team in AP, ensuring compliance with global GDP and GMP regulations.
  • Develop and implement quality systems, ensuring alignment with global quality systems and agency expectations.
  • Establish and maintain strong partnerships with global/regional colleagues and teams that impact Quality and Compliance.
  • Drive the development, implementation, and realization of Permanent Inspection Readiness in collaboration with key stakeholders.
  • Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications, and Market Actions.

Requirements:

  • Bachelor or Master's Degree in Chemistry, Pharmacy, Biology, Microbiology, or Chemical Engineering (or equivalent).
  • Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorization Holders and countries in scope.
  • Strong compliance mindset, excellent project management, and organizational skills.
  • Excellent problem-solving skills, based on science, facts, data, and understanding of regulatory requirements in complex and evolving environments.
  • Ability to be decisive and influence management with demonstrated leadership skills to drive change.
  • Ability to work collaboratively in team settings, across functions, and within matrix organizations to achieve objectives.

Preferred Qualifications:

  • Minimum of 5 years' experience in the pharmaceutical industry, with solid compliance experience.
  • Must have expertise and broad experience in Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GDP and regulatory requirements.

About Organon:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.

Equal Opportunity Employer:

Organon is an equal opportunity employer and welcomes applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

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