Director Clinical Quality Assurance Gcp

vor 5 Monaten

Lausanne, Schweiz Nestle Operational Services Worldwide SA Vollzeit

**Position Snapshot**

Location: Nestlé Health Science Lausanne, Switzerland
Company: Nestlé Health Science International
Act. Rate: Full-Time Act. Rate 100%
Type of contract: Permanent contract

**What we offer at Nestlé**

Flexible work policies in terms of core hours and working from home. Please talk to us during the recruitment process about what flexibility could look like for you
Genuine opportunities for career and personal development
Modern “smart office” locations providing agile & collaborative workspaces
Dynamic international working environment
Attractive additional benefits

**Position summary**

Nestlé Health Science is a globally recognized leader in the science of nutrition, with more than 11,000 employees around the world. With a portfolio of science-based consumer health, medical nutrition, vitamin and supplement brands, and pharmaceutical therapies, we are redefining the management of health.

The Director Clinical Quality Assurance GCP will be a member of the R&D team and collaborate with internal and external partners to complete clinical development functions that ensure compliance with regulatory requirements and quality principles for the conduct of human clinical trials. You will also play a key role in developing and implementing quality standards, processes, and strategies for specific therapeutic areas and across the company as a member of the R&D Quality Team.

We offer a dynamic, inclusive, and international working environment with many opportunities across different companies, functions, and regions. Don’t miss the opportunity to join us and work with different teams in an agile and diverse context.

**A day in the life of a Director Clinical Quality Assurance GCP**
- Develop, implement, and communicate corporate GCP quality strategy, annual plan, and programs for clinical trials.
- Ensure compliance with regulations, standards, internal policies, and procedures.
- Design and oversee inspection readiness and management programs for sponsor and clinical investigator sites.
- Lead the internal audits of key clinical documents (e.g., Trial Master File, Clinical Study Reports, Drug Safety Update Reports, Investigator Brochures) developed for the conduct of human clinical trials.
- Qualify Clinical Research Organizations (CROs), specialty laboratories, and vendors by auditing and establishing Clinical Quality Agreements with them on behalf of Nestle Health Science.
- Oversee and govern the quality partnerships with Clinical Research Organizations that execute outsourced and delegated clinical development activities.
- Develop, report, and act on quality metrics for GCP activities and vendor performance.

**What will make you successful**
- BS in life sciences or related degree.
- 12+ years of experience in Clinical Quality Assurance, preferably in the biotechnology industry.
- Minimum 8 years of senior quality systems leadership in the bio/pharma industry.
- Ability to establish strong relationships with business partners.
- Proven hands-on experience with GCP compliance matters and contractor management in the bio/pharma industry.
- Extensive experience handling government regulatory inspections.
- Excellent communication skills (English) and interpersonal skills.
- Proven successful track record of managing the work of others (e.g., consultants and contractors). This position does not have the responsibility of supervising direct reports at this time.

Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries.

Nutrition can be life-transforming for those who need extra support during short
- or long-term medical challenges, and it can enhance the quality of life of those who are already healthy. With an extensive research network providing the foundation for products that can help people to live their healthiest lives, our commitment to science-based products means that we provide nutritional solutions that can make a real difference in the quality of life of customers, patients, and caregivers.

At Nestlé, we want to help shape a better and healthier world, inspire people to live healthier lives and deliver impact at a scale and pace that makes a difference. We do this by fostering a diverse, friendly, supportive, and collaborative environment, that creates positive disruption, embraces innovation, and empowers people and teams to win. We aim to hire friendly, respectful, inspiring people who care about the people’s lives that we touch every single day.

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