Director Quality Engineer Fda Jobs (NOW HIRING)

 Preparedness today, safer tomorrow.

 Emergent is a leading public health company that delivers protective and life-saving solutions to
 communities around the world.  Here, you will join passionate professionals where our culture is informed
 by our values and commitment to protecting and saving lives.

Job Summary

 
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.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. 

• 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.  

Minimum Education, Experience & Skills

•  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.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $196,000 to $237,100. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.