Executive Director Quality
Executive Director Quality
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Job Description
Job Title: Executive Director Quality
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 industrys 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: Bachelors degree in Chemistry Biochemistry Microbiology Chemical Engineering or a related scientific discipline is required; Masters 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 qualificationsvalidations 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Required Experience:
Director
Employment Type
Full Time
