Title:  Lead-Quality Assurance

Job Title: Lead-Quality Assurance

Reporting to:  Head of 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 speciality chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA. 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 Team Lead Quality Assurance (QA)  serve as operational oversight for the QA function at a large molecule manufacturing plant. This role is critical to ensuring that all QA functions are aligned with regulatory requirements, company objectives, and industry’s best practices. The incumbent will be accountable for overseeing QA, Compliance, Validation, and Documentation, working along with the Head of Quality Assurance in Baltimore. The incumbent will lead the QA strategy for the site, interface with regulatory authorities, and partner cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure compliance and inspection readiness.

Primary Responsibilities

• Responsible for QA activities related to initial qualification and requalification of facilities, equipment, control systems, and clean utilities.
• Coordinate qualification and validation activities with stakeholder departments to ensure the timely completion of projects and milestones.
• Review and approve documents related to qualification and validation activities.
• Ensure QMS documents such as Quality Manual, Site Master File, SOPs, Validation Master Plan, and Quality Agreements are created, reviewed, maintained, and updated as needed.
• Ensure timely issuance and reconciliation of documents and logbooks for related activities.
• Review and approve quality documents, including procedures, and technology transfer documents relevant to Biologics functions.
• Ensure that documents such as BMRs, EOPs, IOPs, specifications, and technology transfer documents are properly developed, reviewed, and updated as needed.
• Conduct training for employees on QMS procedures, operational SOPs, Good Documentation Practices (GDP), and Data Integrity.
• Review and approve procedures (SOPs, EOPs, IOPs) and ensure timely delivery of related training.
• Plan and schedule QA-Biologics activities in alignment with business needs.
• Be responsible and accountable for all Quality Assurance (QA) activities related to Biologics Operations at Syngene.
• Coordinate with cross-functional teams, including Biologics Manufacturing, Corporate QA, and other GxP functions to implement and sustain QMS.

Education & Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline is required; Master’s degree is preferred.
• Experience: 10-15 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 and 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 analytical techniques and validation of methods.
• 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 and validations and product lifecycle quality management.

Additional Competencies:

•        Experience in biologics manufacturing, 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 regulatory and dynamic manufacturing environment.

•        Ability to collaborate effectively with stakeholders both internally and externally, with executive leadership skills.

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.