Job Description

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, 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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