Senior Manager, Quality Control Systems Templating

• Oversight of the AIN-based QC Systems team in support of QC system master data creation, management and qualification
• Collaboration with the global business process owner(s) to resolve issues encountered by the team
• Management of request prioritization in alignment with QC network needs
• Maintaining alignment between sites on use of QC systems and driving further standardization of testing documentation
• Collaboration with other global and site-based QC teams to achieve QC network goals
• Support staff training, career development and performance management of team across all three shifts
• Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements
• Champion process improvements to increase efficiency and productivity
• Assign workload appropriately and strategically based on required interactions with sites in the QC network across multiple timezones
• Evaluate master data requests and categorize based on complexity
• Assign requests taking into consideration priority, network alignment and requested completion timelines
• Track progress of requests in alignment with due dates, and course correct as necessary
• Escalate roadblocks faced by the team to avoid impact to achieving targets
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Anticipate and prevent potential problems with engagement in the network of knowledge sharing in near misses
• Provide updates to the global QC network on metrics, analyzing data and recommending improvements

• Master’s degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience
• Minimum of 5-7 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
• Strong project management skills and experience supervising professionals in a Quality organization working with cross functional and global stakeholders across multiple time zones
• Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control
• Experience with various laboratory computer systems, equipment/instrumentation, and applications
• Excellent written and verbal communication skills, ability to work in a team environment and build relationships with partners
• Track record of building and maintaining a high performing team
• Strong leadership and negotiation skills with a demonstrated ability to influence others
• Demonstrated innovative thinking and ability to transform work organizations
• Demonstrated ability to navigate through ambiguity and provide structured problem solving
• Demonstrated ability to deliver right the first time on schedule in accordance with established Service Level Agreements
• Demonstrated skills in staff motivation, coaching/mentoring and professional development

Reasonable accommodation for individuals with disabilities