Key Responsibilities:

• Leading the implementation of a QC strategy, including method lifecycle strategy, global laboratory digital strategy, new method strategy, to increase the compliance and efficiency of QC laboratories in the RLT organization.
• Enforcing global standardization/integration of business processes and information, data, global equipment standards and application architecture.
• Defining and enforcing current standards, procedures and quality module and directives, global SOPs for analytical laboratories, compliant with cGMP. Maintaining awareness of regulatory requirements affecting the pharmaceutical industry.
• Participation in the preparation for key inspections and, if necessary, support during the inspection.
• Enforcing the QC/AS&T action plan by defining and implementing appropriate roadmaps for QC/AS&T teams across the platform, ensuring compliance, continuous improvement and increasing the effectiveness of all types of QC testing. Initiating, implementing and sustaining initiatives defined by global QC/AS&T.
• Ensuring and promoting cross-site collaboration and transparency of joint initiatives, problems and lessons learned.
• Evaluating and deploying new technologies, systems and software that have the potential to improve the quality of existing QC testing strategies and/or increase laboratory productivity. Continued initiatives to modernize testing functions.
• Supporting the development of on-site platform/team members in technical and leadership skills. Coaching and people development. Delivering training programs developed by the global QC/AS&T function and actively participating in the development of relevant learning materials.
• Implementation and compliance with all instructions and requirements to ensure safe work, protection of the environment and property.
• Representing the company's vision, values and caring for good mutual relations with business partners.

Essential Requirements:

• University degree in Pharmacy, Chemistry, Biology or related subject; higher level degree preferred but not required.
• 10+ years’ experience in GMP-regulated industries including QA/QC in Biotech area.
• Working knowledge of FDA/EMA/ICH regulatory requirements
• Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
• Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain.
• Approximately 25% travel required.

The pay range for this position at commencement of employment is expected to be between $168,000 and $312,000 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.