Manager, All QC

About the role

This role is part of a 24x7 team that supports testing/sampling across all the QC laboratories required for urgent testing/Manufacturing support.

Responsibilities

• Ensures and owns GMP-compliant laboratory operations in alignment with EU GMP, 21 CFR Parts 210, 211, 820, 11, and other applicable GMP guidelines.
• Provides cross-functional leadership and mentorship as the QC laboratory representative.
• Directs four shift supervisors to ensure 24/7 QC team coverage.
• Oversees supervision and scheduling across 223 shifts for the All-QC laboratory team.
• Applies expertise in laboratory methodology and compendial requirements for QC testing that span all the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
• Acts as primary point of contact for their team and first line escalation point in areas of their responsibility.
• Covers analytical data to support test validation, qualification and certification activities.
• Performs investigations, manages complex issues, barriers and problems to support team success.
• Approves data reports within the team and area of discipline/focus, including approval of results.
• Authors protocols, change control requests, and Quality Technical Reports for ensuring successful execution of, qualification, analytical improvement projects, in collaboration with cross-functional teams, as appropriate.
• Proactively identifies technical gaps and areas for improvement related to quality.
• Process and lead internal and external audits proficiently, including commitments on follow up within team & site management, serves as External Leadership cross-functionally.
• Represents QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders.
• Provides regular guidance to direct reports; fosters a positive, collaborative work environment that prioritizes team success; mentors junior staff in quality systems and continuous process improvement.
• Establishes clear requirements, deliverables, measurable goals and targets, and mitigation plans aligned with quality directives, regulatory guidance, and business priorities.
• Ensures timely and appropriate mitigation of issues and deviations.
• Manages complex problem solving, providing mitigation/outcome to management/team.
• Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management.
• Supports key business strategies.
• Conducts approval of complex reports, data of others; Leads complex problem solving through facilitation/escalation.
• Conducts impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations).
• Provides technical support during audits/inspections.
• Ensures adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key customers.
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed.
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution.
• Performs other duties, as assigned.

Requirements

• Bachelor’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 4+ years of related experience OR Master’s degree in chemistry, Microbiology, Biological Sciences, Engineering or related science with 2+ years of related experience Degree with emphasis in life science or engineering preferred
• 4+ years’ experience managing people
• Experience working in a changing, project driven organization
• Previous experience directly supporting function
• Experience with regulatory inspections, investigations and change management preferred
• Experience in pharmaceutical / biological manufacturing operations preferred
• Experience leading others in a pharmaceutical/biological manufacturing facility preferred

Preferred Requirements

• 5+ years of experience in a GMP environment