Executive Director QA
Location: Baltimore
Posted on: June 23, 2025
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Job Description:
Job Title: Executive Director QA Reporting to: SVP Quality
Assurance Department: Quality Location: Baltimore, Maryland About
Syngene Incorporated in 1993, Syngene International Ltd. is an
innovation-focused global discovery, development and manufacturing
organization providing integrated scientific services to the
pharmaceutical, biotechnology, nutrition, animal health, consumer
goods and specialty chemical industries around the world. Syngene’
s clientele includes world leaders such as Bristol-Myers Squibb,
Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative
culture is driven by the passion of its 4240- strong team of
scientists who work with clients from around the world to solve
their scientific problems, improve R&D productivity, speed up
time to market and lower the cost of innovation. At Syngene, safety
is at the heart of everything we do personally and professionally.
Syngene has placed safety at par with business performance with
shared responsibility and accountability, including following
safety guidelines, procedures and SOPs, in letter and spirit. Job
Summary The Sr. Director of Quality provides visionary leadership,
strategic direction, and operational oversight for the Quality
Assurance and Quality control unit at a large molecule
manufacturing plant. This role is critical to ensuring that all
Quality functions are aligned with regulatory requirements, company
objectives, and industry’s best practices. The incumbent will
oversee multiple teams, including QA/QC Operations, Compliance,
Validation, and Documentation working along with the Site Head in
Baltimore. The incumbent is accountable for maintaining cGMP
compliance, driving continuous improvement, and ensuring the
successful release of biologics products while maintaining high
standards for safety, quality, and compliance. The incumbent will
also lead the Quality strategy for the site, and will interface
with all the regulatory agencies and establish processes to ensure
all time audit readiness at the site. Primary Responsibilities
Provide dynamic leadership and strategic oversight for a
cGMP-compliant Quality department supporting large molecule
biologic drug manufacturing. Oversee QA teams responsible for
product release, batch records review, deviation investigations,
CAPA implementation, and stability programs for large molecule
products. Direct the quality assurance efforts for validation of
equipment, processes, cleaning, and facility systems to ensure
consistent product quality and regulatory compliance. Lead the
development, implementation, and execution of quality strategies
and initiatives across all stages of production, from raw material
through final product release. Ensure compliance with USDA, USFDA,
EMA, ICH, and Health Canada regulations, as well as other relevant
global regulatory agencies and standards. Lead regulatory
inspections, customer audits, and prepare responses to regulatory
inquiries, ensuring readiness and alignment with compliance
requirements. Collaborate with cross-functional teams, including
Manufacturing, Regulatory Affairs, and Supply Chain, to maintain
product quality standards and improve operational efficiency. Lead
the implementation of continuous improvement initiatives,
identifying and addressing opportunities to optimize quality
processes and enhance operational performance. Develop and maintain
quality assurance systems, including risk management programs, and
ensure they are followed consistently across the manufacturing
facility. Serve as the subject matter expert on quality-related
matters, ensuring proactive identification and mitigation of risks.
Mentor, develop, and manage a team of Quality leaders; foster a
culture of quality, compliance, and continuous improvement through
training, development, and coaching. Review and approve batch
records, deviations, CAPA reports, change controls, and other
critical documentation for compliance with regulatory standards.
Ensure quality control of all processes related to large molecule
production and maintain a focus on quality assurance throughout
product lifecycle. Operate the QC lab in full compliance to
regulatory requirements employing lean and Six sigma methodologies
Education & Qualifications Education: Bachelor’s degree in
Chemistry, Biochemistry, Microbiology, Chemical Engineering, or a
related scientific discipline is required; Master’s degree
preferred. Experience: 15-18 years of progressively responsible
experience in Quality Assurance within biologics or pharmaceutical
manufacturing environments, specifically for large molecule
products. Regulatory Knowledge: Deep understanding of USDA, USFDA,
ICH, EU, and Health Canada regulations, as well as USP and other
pharmacopeial standards relevant to biologics manufacturing. Audit
Experience: Proven experience managing regulatory inspections and
third-party audits with successful outcomes. Technical Expertise:
Strong working knowledge of biologic production processes, aseptic
techniques, and validation of large molecule drug manufacturing.
Leadership Skills: Demonstrated ability to lead cross-functional
teams, build relationships across departments, and foster a culture
of quality, compliance, and accountability. Training & Development:
Skilled in implementing robust quality systems
,qualifications,validations and product life cycle management
Continuous Improvement: A track record of driving successful
continuous improvement projects to enhance efficiency, reduce
deviations, and increase product quality. Additional Competencies:
Experience in biologics development and commercialization,
particularly in large molecule manufacturing environments.
Knowledge of risk-based approaches in Quality Assurance and product
lifecycle management. Strong interpersonal, communication, and
decision-making skills. Ability to thrive in a fast-paced and
dynamic manufacturing environment. Good knowledge of lean and six
sigma methodologies Equal Opportunity Employer: It is the policy of
Syngene to provide equal employment opportunity (EEO) to all
persons regardless of age, colour, national origin, citizenship
status, physical or mental disability, race, religion, creed,
gender, sex, sexual orientation, gender identity and/or expression,
genetic information, marital status, status with regard to public
assistance, veteran status, or any other characteristic protected
by applicable legislation or local law. In addition, Syngene will
provide reasonable accommodations for qualified individuals with
disabilities.
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