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The Position

Quality & Compliance Lead - Pharma PDQ

Location:Kuala Lumpur

Are you a seasoned Quality & Compliance professional ready to make a significant impact in the pharmaceutical industry Join our dynamic Pharma PDQ team as a Senior Quality & Compliance Lead and play a pivotal role in ensuring global regulatory compliance and patient protection.

The Opportunity:

This critical position is responsible for leading and managing the identification of medical compliance risks escalating them to the Chief Medical Officer and aligning medical compliance efforts across our global Affiliates. You will be the primary point of contact for country medical directors and the Deputy Chief Medical Officer regarding Affiliate Oversight owning the process identifying risks and addressing escalations through the OneRoche & Medical Compliance Governance framework.

Beyond regulatory compliance you will be instrumental in ensuring inspection readiness and leading major regulatory authority inspections globally encompassing strategic planning management and execution of all inspection-related activities. Your collaborative approach will be essential in working with sites and cross-functional study teams to proactively identify and address potential risks.

Key Responsibilities:

• Medical Compliance:Accountable for affiliate oversight data analysis acting as an escalation point for country medical directors and contributing to continuous improvement initiatives.
• Governance & Escalation:Ensure escalations are captured and addressed through appropriate case management and enable the escalation of Affiliate topics through the OneRoche Medical Governance process.
• Risk Management:Implement the Risk Management Process for Affiliates priority countries identify and monitor cross-affiliate trends and support risk mitigation strategies.
• Medical Compliance & Strategy Integration:Act as a catalyst to embed medical compliance strategy at Affiliates fostering knowledge skills and mindset within the OneRoche Governance & Medical Compliance ecosystem.
• Networking:Partner with various internal and external groups build strong relationships with the countrys medical director community and provide comprehensive compliance assessments.
• Inspections:Manage all aspects of inspection readiness represent the organization during major health authority inspections (e.g. FDA EMA PMDA MFDS) and lead mock inspections.

Qualifications & Experience:

• Masters Bachelors degree or equivalent in a scientific or quality-related field or equivalent combination of education training and experience.
• Demonstrated applied knowledge of global regulatory requirements in the pharmaceutical industry particularly in clinical (GCP) pharmacovigilance (GVP) device or Quality.
• Expert knowledge of FDA EU and ICH GCP guidelines and regulatory compliance.
• Fluency in written and spoken English and Mandarin bilingual or multilingual skills are required.
• Proven ability to manage multiple priorities in a dynamic fast-paced environment and lead complex inspection activities.

Skills and Competencies:

• Strong digital and data literacy proficiency Google suite.
• Advanced communication and presentation skills.
• Proven ability to manage multiple priorities in a dynamic fast-paced environment and lead complex inspection activities.
• Ability to influence negotiate and work effectively in an international multicultural matrix organization.
• Strong critical thinking analytical problem-solving and decision-making skills.
• Strong interpersonal skills leadership experience in global project teams and excellent project management skills.
• Strategic insights analysis high learning agility proactive risk-based approach and an enterprise-wide mindset.

If you are a proactive leader with a strong understanding of quality and compliance within the pharmaceutical development landscape we encourage you to apply and contribute to our mission of accelerating the delivery of medicines to patients.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.