Local Quality Responsible

Posted Yesterday
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Hiring Remotely in Nairobi, KEN
Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and operate the local Quality Management System for clinical and pharmacovigilance activities, ensure compliance with GCP/GVP and local regulations, manage audits/inspections, drive CAPA and continuous improvement, oversee external vendors, and establish local training and risk management frameworks.
Summary Generated by Built In

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity

As the Local Quality Responsible, you will lead and shape the strategic and operational performance of our Local Quality Management System (QMS). In this role, you will champion a robust quality culture, ensuring our clinical and pharmacovigilance activities consistently align with global standards and local regulatory requirements. You will serve as a strategic partner to leadership, driving continuous improvement and proactive risk management to deliver safe, high-quality solutions for patients.

Key Responsibilities:

  • Lead the Affiliate Quality Management System (QMS): Direct the operational execution of our Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality standards, ensuring compliance with local regulations.

  • Champion a Culture of Quality: Partner closely with local and international leadership teams to promote compliance, manage institutional risks, and drive regular Management Review processes.

  • Oversee Audit & Inspection Readiness: Act as the primary point of contact for clinical and pharmacovigilance audits and Health Authority inspections, leading local coordination and response strategies.

  • Drive Continuous Improvement & CAPA: Facilitate root-cause analyses, manage the Corrective and Preventive Action (CAPA) process, and address process deviations swiftly and effectively.

  • Manage Strategic Service Providers: Oversee external GCP/GVP vendors by establishing robust monitoring plans, regular risk assessments, and performance evaluations.

  • Empower Through Training: Establish and maintain local training frameworks to ensure all relevant personnel are fully equipped and compliant with core global standards.

Who You Are
You are a highly motivated quality professional who thrives on collaboration, strategic thinking, and continuous improvement. You possess excellent listening and decision-making skills, with a proven ability to influence teams, build consensus, and navigate challenging compliance landscapes seamlessly.

Qualifications & Experience:

  • Education: Bachelor’s degree in science, biology, or a related field (Advanced degree or specialized quality certification is preferred).

  • Experience: 5+ years of professional experience within the biopharmaceutical industry or an equivalent regulated environment.

  • Regulatory Expertise: Demonstrated hands-on knowledge of GCP and GVP regulatory requirements, along with experience navigating Health Authority inspections or audits.

  • Quality & Risk Systems: Solid understanding of Quality Principles (such as ISO 9001 standards) and proactive Risk Management frameworks.

  • Global Collaboration: Strong verbal and written communication skills in English, with a track record of effectively managing stakeholders across a matrixed or international organization.

Let’s thrive together in a culture built on trust, collaboration, respect, and high performance.

Note that a full job description is available at request.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Skills Required

  • Bachelor's degree in science, biology, or related field
  • 5+ years professional experience in biopharmaceutical or regulated environment
  • Hands-on knowledge of GCP and GVP regulatory requirements
  • Experience navigating Health Authority inspections or audits
  • Understanding of Quality Principles (e.g., ISO 9001) and Risk Management frameworks
  • Strong verbal and written communication skills in English and stakeholder management in matrix organizations
  • Advanced degree or specialized quality certification

Roche Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.

  • Retirement Support U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
  • Leave & Time Off Breadth Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
  • Healthcare Strength Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.

Roche Insights

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The Company
Provincia de Buenos Aires
93,797 Employees
Year Founded: 1896

What We Do

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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