Director, Quality Control

Emergent Biosolutions•Canton, MA

1d•$196,000 - $237,100

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. The Director, Quality Control (QC) is responsible and accountable for all aspects of Quality Control and Sterility Assurance for the GMP vaccine Drug Substance (DS) manufacturing site in Canton, MA. This role provides strategic and operational leadership for QC laboratories supporting raw materials, in-process, release, stability, microbiology, environmental monitoring, and sterility assurance activities, ensuring continuous compliance with FDA, EMA, WHO, and global regulatory expectations. The Director, QC is a key member of Site Quality Management and operates with independence from manufacturing, exercising final authority for QC-related quality decisions. The incumbent partners closely with site leadership, Manufacturing, MSAT, QA, and Global Process Owners (GPOs) for QC support systems (e.g., LIMS, data integrity, supplier quality, analytical and microbiological methods, EM programs, Annex 1 compliance) to ensure robust lifecycle management, inspection readiness, and continuous improvement aligned with global standards.

Requirements

Bachelor’s degree in Analytical Chemistry, Biochemistry, Microbiology, Biological Sciences, or related discipline required; Master’s or PhD strongly preferred.
15+ years of progressive experience in Quality Control within GMP biologics or vaccine manufacturing environments, including Drug Substance operations.
Minimum 10 years of demonstrated people and organizational leadership experience managing complex laboratory organizations.
Deep expertise in FDA, EMA, ICH (Q7, Q9, Q10), pharmacopeial standards, data integrity, and global regulatory expectations for biologics and vaccines.
Demonstrated leadership in sterility assurance, microbiology, environmental monitoring, contamination control strategies, and Annex 1 implementation.
Strong technical background in analytical, biochemical, and microbiological methodologies (e.g., chromatography, electrophoresis, bioassays, PCR, ELISA, sterility and endotoxin testing).
Proven experience with analytical and microbiological method lifecycle management, technology transfer, and validation.
Demonstrated success leading global and regulatory inspections and managing post-inspection commitments.
Strong applied statistics, data trending, and process capability analysis skills.
Executive-level communication, decision-making, and influencing skills within matrixed and global organizations.

Responsibilities

Provide strategic and visible leadership for all QC and Sterility Assurance functions, fostering a culture of quality, data integrity, accountability, and continuous improvement.
Ensure full CGMP compliance for chemical, microbiological, biological, and physical testing of raw materials, in-process materials, drug substance, stability, environmental monitoring, and critical utilities.
Maintain independence of the QC function and exercise final authority for acceptance or rejection of materials, intermediates, and GMP drug substance, including issuance and approval of Certificates of Analysis.
Own and manage site QC programs including sampling plans, retain samples, stability programs, EM programs, sterility assurance strategy, and control of contamination and cross-contamination.
Provide executive leadership for Annex 1 implementation, sterility assurance strategy, contamination control strategy (CCS), and alignment with current FDA/EMA expectations for aseptic and biologics manufacturing.
Oversee method lifecycle management including development, qualification, validation, transfer, troubleshooting, and continuous optimization of analytical and microbiological test methods.
Ensure effective management of OOS, OOT, deviations, investigations, CAPAs, and change controls associated with QC operations, with strong root cause analysis and trend oversight.
Partner with Global Process Owners to deploy and sustain QC support systems (e.g., LIMS, laboratory data integrity, global methods, supplier quality interfaces) and ensure alignment with global standards and inspections.
Lead inspection readiness and represent QC during regulatory inspections, audits, and customer engagements; ensure timely, accurate, and risk-based responses to observations.
Provide oversight of external and contract laboratories, ensuring appropriate qualification, quality agreements, and performance monitoring.
Ensure robust data trending, statistical analysis, and reporting to support Annual Product Reviews (APR), Quality Management Reviews (QMR), and lifecycle process verification.
Develop and execute QC workforce, capability, and succession strategies; recruit, mentor, and develop high-performing leaders and technical experts.
Establish and manage departmental budgets, capital planning, and resource allocation aligned with site priorities and long-term capacity needs.
Promote effective cross-functional collaboration with Manufacturing, MSAT, Engineering, Supply Chain, and QA to proactively manage risks to product quality and supply continuity.