Quality Assurance Director

4 weeks ago

Shanghai, Shanghai, China Organon Full time

Job Description

Organon is seeking a highly skilled Quality Assurance Director to oversee the quality of our products manufactured at External Entities (EEs). The successful candidate will be responsible for ensuring that all activities at the EEs are conducted in accordance with approved processes and procedures, and that products are manufactured and tested in compliance with regulatory requirements.

Key Responsibilities

  • Develop and implement quality systems and processes to ensure compliance with regulatory requirements.
  • Conduct regular audits and inspections to ensure adherence to quality standards.
  • Manage a team of Quality Assurance professionals to ensure effective quality control and assurance.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Develop and maintain quality metrics and reports to track performance and identify areas for improvement.

Requirements

  • Minimum four year degree in Science, Engineering or other relevant technical discipline.
  • At least 5 years of experience in pharmaceutical production and quality management, with at least 3 years in sterile manufacturing and quality management.
  • Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.
  • Ability to work across boundaries and demonstrated interpersonal, relationship building and leadership skills.
  • Communicates in English and Chinese, both verbally and in writing.

Preferred Qualifications

  • Prior management experience.
  • Moderate level of contractual and financial awareness.
  • Previous experience participating in regulatory inspections.
  • Be conversant with all domestic and foreign regulations and compendia governing plant operations.

About Organon

Organon is a 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

Organon offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from candidates with a diverse background.

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