Senior Director, Quality and Regulatory Affairs, Advanced Staining and Imaging
Vista, CA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Job Description:55 people have viewed this job
This is a senior management position with quality and regulatory (QRA) leadership responsibilities for the Advanced Staining & Imaging (ASI), the largest and moststrategic global business unit of Leica Biosystems.Provides leadership and direction through managers and senior professional staff. Is accountable for the performance and results of the global QRA team, including all aspects of regulatory affairs (including strategies and submissions) quality assurance, quality systems, product quality, and compliance.Serves as a business partner who effectively leads QRA while also contributing to the overall success of the operating company.The QRA leader has a proven track record of strong organizational leadership and building effective multi-site teams in the medical device/IVD regulated industry.Is able and motivated to develop further into roles with greater responsibility. Ability to develop and drive regulatory strategies for novel products.
• Develop and lead strategic regulatory and quality initiatives to support growth of the Advanced Staining & Imaging (ASI) business unit.Integrate strategies across ASI’s broad anatomic pathology IVD portfolio (e.g. companion diagnostics, protein staining, molecular methods, digital imaging and analysis).
• Senior leadership of the ASI quality assurance and regulatory affairs organization across all applicable sites including:Vista CA, Danvers MA, Newcastle UK, Amsterdam NE, Dublin Ireland, Bangalore India, and Melbourne Australia.
• Drives effective collaborations with Medical Affairs, Clinical Affairs and Scientific Affairs to ensure patient needs and clinical trial objectives are a shared focus leading to scientifically robust and compliant strategies and product approvals.
• Is accountable for the performance and results of the QRA organization including, but not limited to: compliance, growth initiatives (i.e. registrations, submissions, supporting clinicals), talent & organizational development, and departmental objectives.
• Develops strategies and plans to meet performance objectives of the organization.
• Effectively delegates initiatives and tasks.
• Member of the ASI senior leadership team and reports dotted-line to the ASI Global Vice President.
• Member of the LBS QRA management team with responsibilities for tracking and reporting KPIs and driving improvement of performance metrics.Responsible for global QRA initiatives, as assigned.
• Lead and develop the ASI QRA team according to the Danaher Leadership Anchors (e.g. Charts the Course, Builds Teams, Drives Innovation, Acts with Integrity). Responsible for developing associates through continuous development planning (D4G); drive successful and measurable employee engagement.
• Manage timelines, budgets and resource allocation according to requirements of the business.
• Effectively lead through Danaher Business System (DBS) tools to drive continuous improvement
• Bachelor’s degree in science, medical or technical field and 15+ years’ experience with increasing responsibility in medical device Regulatory Affairs including demonstrated success as leader of QA/RA or Regulatory Affairs for a $0.5b+ complex business unit.
• Technically adept at understanding the IVD market and associated technologies (i.e. protein, molecular, imaging, next gen).
• Dynamic leader with a minimum of 8+ years people leadership including managing a large team across multiple global sites.
• Must have a proven track record of successful regulatory strategies, 510k clearances and PMA approvals.Experience negotiating with regulators.
• Experience in in vitro diagnostics, companion diagnostics or digital imaging is highly desirable.
• Proven history of successfully leading in a global and dynamic environment while driving team performance. Ability to be a champion for change in the organization.
• Ability to translate ASI’s vision and objectives into challenging and meaningful goals for the global QRA team. Moves strategy to action.
• Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators.
• Strong commitment to quality and compliance.Organized and detail-oriented
• High level of initiative, self-motivation and energy.
• Reliable and responsive.
• Customer focused.
• High level of integrity.Consistently uses sound judgment.Operates with transparency and is trusted.Demonstrates humility and self-awareness.
Travel % of Travel, include approximate overnight stays per week
• Travel expectations for this role are high (50% +) for initial 4 months then medium(25%)
• This role is based at one of the US-based LBS ASI sites: Danvers MA or Vista CA
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.