**Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Sr. AD, QC ASAT and leads the analytical science and technology function that enables rapid, compliant onboarding of new client products and robust lifecycle management of methods for commercial GMP manufacturing. This role oversees method validation/transfer (per ICH Q2(R2)/Q14), specification setting and maintenance, reference standard and critical reagent programs, stability program ownership, analytical trending & control charts, and technical consulting for investigations, OOS/OOT, and compliance. The leader will also own or oversee local Management System Owners (MSOs) for Stability, OOS, Testing Specifications, and Reference Standards to ensure strong governance, inspection readiness, and continuous improvement. This position offers a base salary typically between (170,000) and (269,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  Please reach out Talent Acquisition or your HR Business Partner for more information. **Duties & Responsibilities** **Strategic Leadership & Vision** • 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. **New Product or Method introduction** • New Product Introduction (NPI) & Tech Transfer: 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. • Method Validation/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. • Regulatory & Audit Readiness: Support client/regulatory inspections, author/review source documents, and ensure alignment with filings and global guidelines. **Project Team & Client interface** • 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 **Analytical Lifecycle Management and Support** • Method Lifecycle Management: 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 **Team Leadership & Developmen** t • 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. **Requirements** • 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. The job holder must be an expert in: **Communications** • Written: Prepares and approves technical documentation; communicates QC strategy and priorities clearly across functions. • Verbal: Represents QC in cross-functional and cross-divisional forums, and inspections; articulates technical decisions and risk-based rationales effectively. • Digital Use: Champions the use of digital tools for data integrity, automation, and performance tracking; ensures consistent and compliant system use across QC teams. Leadership & Stakeholder Management • Proven track record in compliance leadership and inspection support. • Leads team structure and development; navigates change and ambiguity with confidence. • Manages internal and external QC relationships, including service providers and cross-functional or cross-divisional stakeholders. • Sponsors and drives continuous improvement initiatives; aligns QC performance metrics with departmental and site-level outcomes. • Leads QC integration and standardization with global networks and shared practices. **Technical & Operational Excellence** • Oversees complex QC operations including QC project management, method validation and transfer, reference standard qualification, and the site’s stability program. • Makes risk-based decisions on compliance and science; ensures robust governance of QC deliverables. • Defines standards for assay monitoring and critical reagent qualification; ensures insights inform decision-making and regulatory readiness. • Supports strategy for inspection readiness and external communications related to QC operations. **Eligibility Requirements:** + 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 **Desired Skills, Experience and Abilities** **Continuous Improvement & Innovation** • 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. **Stakeholder & Cross-Functional Collaboration** • 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. **Financial & Resource Management** • 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. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.