Quality Assurance Affiliate (QAA) Head

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche!

In Pharma Development Quality (PDQ) we strive to demonstrate confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes (GVP, GCP and Medical Device).

The Quality Assurance Affiliate Head leads the strategy, planning, and execution of quality assurance for affiliates while managing an expert team of Quality Leads to deliver Affiliate Quality Conclusions on the areas that are Critical to Quality.

Additional responsibilities:

• Partner with global/local and internal/external stakeholders to inform quality assurance strategy.

• Promote actionable insights from audit program outcomes to demonstrate confidence in Healthcare Solutions.

• Ensure Quality Leads fulfill accountabilities in delivering robust Quality Conclusions, including audits and local Health Authority inspections.

• Provide transformational leadership as a member of the QA Leadership Team.

• Develop and refine global strategies for the design and implementation of Affiliate Quality Conclusions.

• Coach team members across multiple geographies to maximize their development and impact.

• Act as a Quality ambassador in high-impact internal and external initiatives.

Requirements:

• 12 years of relevant experience including a minimum of 7 years of leadership experience.

• Strong experience in the Pharmacovigilance space with a quality mindset

• Profound knowledge and experience in the Pharma affiliate business acumen.

• Ability to connect beyond the country and demonstrate cross-functional leadership.

• Strong stakeholder management and influencing skills.

• Analytical thinking, system understanding, and familiarity with analytics and data visualization tools.

• Effective communication and exceptional negotiation skills.

• Demonstrated Roche Values, VACC Leadership, leadership commitments, core competencies, cultural and organizational agility.

• Entrepreneurial and growth mindset.

• Fluency in written and spoken English.

• Master's, Bachelor's degree or equivalent in a scientific/quality-related field.

• Experience in Pharmacovigilance audit program design and methodology, including CAPA Management.

• Proven ability to articulate a strategic vision and lead self-managed teams.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $190,600 - 354,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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