Quality Assurance Manager
Pharmanovia
Job Description
Quality Assurance Manager - (CMO Oversight) - Chennai, Vadodara or Mumbai (Preferably Chennai) - Full-Time
About the CompanyPharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally by revitalising niche, trusted medicines. Since our founding in 2013, we have grown consistently, supported by a diverse global team of over 300 employees across 29 nationalities.
Our therapeutic focus includes Cardiovascular, Oncology, Endocrinology and Neurology, and we partner with leading pharma companies to maximise the lifecycle value of established medicines.
About the RoleWe are hiring a Quality Assurance Manager (CMO Oversight) to oversee contract manufacturing organisations (CMOs) and ensure compliance, product quality, and operational excellence across the external supply network. This is a hands-on, cross-functional role within a fast-growing organisation, offering exposure across multiple products, markets and manufacturing partners.
ResponsibilitiesProvide end-to-end quality oversight of CMOs, covering both project phases and commercial operationsLead the authoring, review and negotiation of Quality Technical Agreements (QTAs), ensuring timely completion aligned to project timelinesOversee deviations, change controls, complaints and investigations across external partnersLead and review OOS investigations and root cause analysis, ensuring timely escalation to Manager/QP where requiredDrive timely closure of CAPAs, collaborating with internal teams and external partnersPlan and execute external supplier audits, maintaining audit schedules and tracking KPIsSupport technology transfer activities and quality aspects of new product introductionsOversee product stability programme setup and monitoringIdentify, assess and escalate quality risks associated with products and processesBuild and maintain strong quality relationships with CMOs and affiliate partnersCollaborate cross-functionally with Quality, Technical, Supply Chain and Regulatory teamsSupport continuous improvement initiatives to enhance quality systems and operational efficiencyComplete ad hoc quality activities in line with business needs
QualificationsBachelor's degree in Pharmaceutical Sciences or related field (postgraduate qualification desirable)Strong experience in pharmaceutical quality within external manufacturing (CMOs/CDMOs)In-depth knowledge of GMP, EU GMDP, ICH guidelines and quality systemsProven experience managing deviations, investigations (OOS), CAPAs and change controlsExperience authoring and negotiating Quality Technical Agreements (QTAs)Experience supporting and/or leading supplier audits and audit readiness activitiesBackground in manufacturing, QC, validation or technical operationsExperience across oral solid dosage forms (sterile products advantageous)
Preferred SkillsStrong attention to detail and ability to review critical quality documentationExcellent communication and stakeholder management skillsAbility to work independently and within cross-functional teamsProactive, organised and solutions-focused approachStrong IT skills (MS Office: Excel, Word, PowerPoint, Teams)
Pay range and compensation packageWe offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.
Equal Opportunity StatementPharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual's race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.
Pharmanovia will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.