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Director Quality - Product Leader Women's Health (Remote)

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Organon

Today

  • Job
    Full-time
    Expert Level
  • Amsterdam
    Remote

AI generated summary

  • You must have a degree in a related field, 10+ years in Pharma, expertise in Quality and Manufacturing, strong problem-solving, project management, communication skills, and global GMP knowledge.
  • You will ensure compliant supply, lead significant investigations, partner on analytical and technical initiatives, support continuous improvement, review change controls, and analyze complaints.

Requirements

  • Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, chemical engineering (or equivalent)
  • At least 10 years of experience in the Pharmaceutical industry, with solid knowledge of global GMPS and global regulatory requirements
  • Expertise and broad experience in Quality and Manufacturing and in product development and registration including solid knowledge of global GMP and regularity requirements experience in Women's Health franchise preferred
  • Excellent problem solving skills based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; be able to apply sound risk management principles
  • Excellent project management and organisation skills and strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures
  • Demonstrate ability manage across a broad framework of initiatives and influence employees across all levels and all functions and ability to create simplicity out of complex environments
  • Strong demonstrate community skills by verbally as well as well as writing in English

Responsibilities

  • Provide support and direction to ensure continuous compliant supply across nodes and to resolve testing and release issues
  • Support and direct Significant Investigations (SI) and understand franchise/product risks and impact due to significant investigations, and contribute to fact finding meetings
  • Partner with the Analytical Product Steward and provide support/sponsorship when required for analytical initiatives like method and compendial updates
  • Partner with the Technical Product Stewart and provide support/sponsorship when required for technical initiatives
  • Support and lead continuous improvement initiatives include value stream mapping, Kaizen events etc
  • Partner with technical product suit provided list review of the annual product review (AQR)
  • Provide input and reviews for change controls and support their prioritisation
  • Complaints partner with Technical Product Steward to provide holistic review

FAQs

What is the job title for this position?

The job title is Director Quality Assurance, Product Leader Women's Health.

Is this position remote?

Yes, this is a remote opportunity with a preference for candidates located in Europe.

What is the primary purpose of the role?

The primary purpose of the role is to provide end-to-end product quality oversight for the women's health franchise and to drive innovative compliance and manufacturing excellence.

Who will the Director Quality report to?

The Director Quality will report to the Associate Vice President (AVP) Internal manufacturing quality.

What percentage of time is expected for travel in this role?

The amount of travel in this role will be around 10 to 20% of the time.

What level of experience is required for this position?

At least 10 years of experience in the Pharmaceutical industry is required, with solid knowledge of global GMPs and global regulatory requirements.

What educational qualifications are needed for this role?

A Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, chemical engineering, or an equivalent field is required.

What specific experience is preferred for this role?

Expertise and broad experience in Quality and Manufacturing in product development and registration specifically in the Women's Health franchise is preferred.

Are there any specific skills that the candidates must possess?

Candidates must possess excellent problem-solving skills, project management and organization skills, and strong interpersonal and communication skills.

What kind of working environment does Organon emphasize?

Organon emphasizes an inclusive and diverse working environment and is committed to creating an inclusive environment for all applicants.

Does Organon accept unsolicited applications from search firms?

No, Organon LLC does not accept unsolicited assistance from search firms for employment opportunities.

Is relocation provided for this role?

No, there is no relocation provided for this role.

Will the company sponsor a visa for this position?

No, Organon will not provide visa sponsorship for this position.

What is the annualized salary range for this position?

The annualized salary range varies by local market and is not specified in the job description.

Is there a valid driving license required for this role?

Yes, a valid driving license is required.

How does Organon view its employees?

Organon views its employees as essential to delivering high-quality health solutions and emphasizes collaboration across internal manufacturing facilities.

Here for her health

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Organon is a global healthcare company dedicated to improving the health and well-being of women throughout their lives. They focus on a broad portfolio that includes reproductive health, heart disease, dermatology, and more, with the aim of addressing health needs that are often underprioritised. Their ultimate mission is to help women live healthier and longer lives by providing innovative and impactful medical products and solutions. Organon's purpose is to create a better and healthier everyday life for women around the world, while contributing to advancements in global health care.