Director Quality & Regulatory Strategy

Indiana, United States of America

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The Position


Works closely with the Quality & Regulatory Leadership Team to develop, communicate, execute and sustain Q&R strategic initiatives. Provides direction and oversight on major Q&R projects. The scope includes: Strategy development and Intelligence, cross-site and cross function project leadership, and Q&R IT landscape. Overall responsibility to lead complex projects, including the identification, funding, justification, design, implementation, delivery and achievement of expected results; represents the projects within Global Q&R.

Key stakeholders of this position will be across most functional areas of the QRLT, BA/BU Heads, Global Functions and Regions or Country Managers.

Participates with other leaders to establish strategic plans and objectives. May develop corporate policies and authorize their implementation. Participates in development of methods, techniques and evaluation criteria for projects, programs and people for the company. Has in-depth knowledge of the company, business strategies and functional area. Regularly interacts with executives both internal and external and/or major customers for the purpose of influencing and negotiating. Provides direction to subordinate managers and/or high level individual contributors and typically has responsibility for a broad functional area with multiple departments, product groups or service areas.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Key Roles & Responsibilities:

  • Lead the development of the overall Q&R strategic plan working in close collaboration with the Quality & Regulatory Leadership Team. Identifies major global initiatives that cross multiple sites and ensures that the most impactful programs are recognized, implemented and sustainable performance delivered. Manages all aspects of the overall portfolio projects including budget.
  • Development of approach/methodology to create a comparable and consistent fact-base. Work with Data Analysts to develop templates, tools and processes to collect and maintain relevant data.
  • Use of data and tool outputs to identify opportunities and support the development of the overall strategy. Included in this will be the identification of comparable/meaningful external benchmarks (inside and outside our industry).
  • Using available data and experience, work with the rest of the Q&R Strategy group to develop a Q&R master plan, supporting mid- and long-term planning. Key to this activity will be scenario analysis/business case development, risk analysis and understanding mid/long term demand requirements (including assumptions). Responsible for analyzing and recommending tools / methodologies which will help streamline / improve the value of these analyses in the future.
  • In close cooperation with major stakeholders, develops and recommends the appropriate governance models/structures to support the strategy and recommendations impacting Quality and Regulatory. This activity includes developing RACI matrices for processes and activities but also to recommend metrics that will drive the desired behavior.
  • Permanently optimizes processes in order to increase quality and efficiency standards

Minimum Qualifications:

  • Bachelor's Degree in Business, Sciences, Engineering, Business Development, or related field requiring strategic and analytical thinking.
  • 10+ years work experience in the Diagnostics, Medical Device or Pharmaceutical Industry.
  • Ability to think strategically and systemically, analyze complex business issues and opportunities and utilize sound judgment in establishing the appropriate objectives and direction.
  • Excellent stakeholder management skills.
  • Solid understanding of quality, regulatory and manufacturing operations to facilitate the development of credible plans.
  • Strong leadership skills including the ability to get things done through task teams composed of members with direct and indirect reporting relations.
  • Builds bridges across geographical, cultural and functional boundaries to enhance collaboration, including the strong interpersonal skills to successfully perform in a complex global matrix environment.
  • Demonstrated track record for results, leadership and change management. A proven history of driving significant change in a short period of time in a positive and non-disruptive manner.
  • Proven track record of consensus building and conflict management in challenging in situations.
  • Executive presence including confidence, performing well under pressure and decisiveness
  • Strong business acumen with solid knowledge of operational accounting and finance


  • MBA Degree

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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