Boehringer Ingelheim · 1 day ago
Sr. AD, QC ASAT, Fremont CA
Fremont, CA
Full-time
Onsite
Senior Level
$170K/yr - $269K/yr
5+ years expBoehringer Ingelheim is a global leader in the pharmaceutical industry, committed to improving patient health. They are seeking a Senior Associate Director for Quality Control Analytical Science and Technology to oversee the analytical science function, ensuring compliance and effective lifecycle management of methods for commercial GMP manufacturing.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensure that Quality Culture principles and company goals are clearly understood and embraced by all team members. Role model Our Behaviors and actively foster a culture of integrity, collaboration, and accountability, encouraging adherence and engagement across the team
Define and implement the strategic direction for QC department in alignment with site and global objectives with focus on compliance
Drive and lead standardization and harmonization of QC practices and across the global network
Sponsor and lead initiatives that enhance lab excellence, modernization, digital transformation
Shape and contribute to global QC standards, policies, and processes
Plan and execute analytical strategy for incoming products—gap assessments, risk assessments, method readiness plans, validation/transfer protocols, execution, and reports, stability program, reference standard qualification
Ensure phase-appropriate design and execution (ICH Q2(R2)), robustness/risk assessments, and data packages suitable for PPQ and commercial control
Apply risk-based decision-making to balance compliance and operational efficiency for complex and high-impact situations
Support client/regulatory inspections, author/review source documents, and ensure alignment with filings and global guidelines
Act as QC representative in internal and external client project teams
Ensure QC deliverables meet global and local regulatory expectations
Ensure newly implemented products and methods adhere to timeline and budget within QC
Initiates generation of change orders in case of scope change
Establish control strategy and performance monitoring aligned to ICH Q14, including ongoing trending, control charts, periodic reviews, and continuous improvement
Designs programs for qualification and requalification of critical reagents and reference standards
Responsible for setting up and monitoring the ongoing stability program in accordance with regulatory requirements, client requirements and internal procedure
Lead, coach, and mentor managers and scientists to build and maintain a high-performing, resilient team
Drive talent acquisition, succession planning, and career development
Ensure training programs are in place and performance is actively managed
Foster a culture of accountability, collaboration, and continuous learning
Act as deputy to Head of QC, ensuring continuity and strategic support
Qualification
Required
Bachelor's degree in engineering, chemistry, biology, or a related discipline with 10+ years of experience in QC operations within the pharmaceutical industry, or
Master's degree in engineering, chemistry, biology, or a related discipline with 5+ years of relevant QC experience
Minimum of 5 years of management experience, including leading teams and cross-functional collaboration with departments such as Quality, Process Science, and Manufacturing
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Preferred
Ensures LEAN principles to streamline workflows and improve efficiency are established for QC processes
Drive process improvements and foster a culture of innovation and scientific excellence
Champion the use of innovative and digital tools to enhance lab performance and reduce manual effort
Establish, monitor and act on performance metrics to improve throughput and compliance for QC
Maintain strong interfaces with Development, Regulatory, Project Management, and Manufacturing
Foster rapid communication and effective handovers across departments and global sites
Collaborate with external clients and partners to ensure alignment and support dispute resolution
Prepare and manage headcount, operating, and capital budgets
Optimize resource allocation across QC functions to meet departmental targets
Use budget strategically to support modernization, capability building, and process improvements
Ensure QC contributes to the success of the site as a reliable and competitive contract manufacturing partner
Benefits
Competitive compensation and benefit programs
Opportunity to consider higher compensation above this range based on business need, candidate experience and or skills
Role specific variable or performance based bonus
Company
Boehringer Ingelheim
Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.
Founded in 1885Ingelheim Am Rhein, Rheinland-Pfalz, DEU
10001+ employees
H1B Sponsorship
Boehringer Ingelheim has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (4)
2023 (11)
2022 (7)
2021 (17)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Christian Eckermann
Corp. SVP BioPharma Network
Clemens Twardy
Corporate Vice President, Head of Global Supply Chain and Lifecycle Management Animal Health
Recent News
2026-01-23
Hindu Business Line
2026-01-22
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