Job Summary

We are looking for a quality-oriented person with an analytical and scientific mindset to join our dynamic multidisciplinary team as a QA Manager that will be responsible for the Higi site compliance and operational compliance of the clinical laboratories. The QA Manager will operationally support the daily activities including review and approval of procedures and documents for the analytical and microbiological activities, manage external audits from heath authorities and customers, support/execute internal audits, conduct check rounds to monitor the compliance of the laboratory areas and the performance of the processes and activities, review and approve quality investigations and change controls, provide quality metrics in support of quality reporting. The QA Manager will closely interact with the other IMSCQ.PQM and CSQ team members, our TDS business partners and other business and quality departments to ensure quality is incorporated in processes and support the informed decision-making process.

Together with this exciting function in a dynamic and international environment, we ensure diversity in your work and support personal development.

Location

Mumbai

You will be responsible for:

- Support, coach, develop team in reaching quality, business and personal objectives

- Ensure quality oversight on the TDS laboratories Synthetics Higi and their contract laboratories.

- Connect and develop strong relationships with quality and business partners and stakeholders to address issues, opportunities

- Proactively and continuously challenge the organizational performance and develop/implement improvements.

- Ensure that GMP activities in the laboratories and their contractor laboratories are being executed in compliance with the regulations for IMP and national and international cGMP requirements.





- Organize and host quality meetings such as CPA Board, QIP, prepare and support QSMR meetings.

- Organize, prepare and support by the team for external audits and inspections e.g. USFDA, EMA, Customer, and internal inspections e.g. global compliance in the TDS laboratories.

- Ensure timely review and approval of quality documents to support the development projects and comply with global Johnson Johnson (JJ) policies, IMP regulations, and national and international cGMP requirements

- Ensure that evaluation and approval of events, deviations, and CAPAs are timely performed, the records meet quality and compliance requirements and adequate corrective and preventive actions are taken.

Required skills

- Leadership and decision-making skills to meet business objectives and a highly dynamic business environment

- People management skills, as direct and/or indirect manager or project manager.

- Ability to work in a matrix organization, across organizational boundaries through influencing, negotiation and partnering.

- Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.

- Excellent organization and interpersonal skills; ability to work with various partners and influence decision processes.

- General knowledge of pharmaceutical product development and understand how analytics contribute to this process.





- Up-to date knowledge of applicable regulations and industry standards.

- In depth scientific and analytical knowledge, ability to quickly assimilate new requirements, new modalities such as techniques, product types.

- Transparent understanding and ability to perform risk assessment and develop/provide appropriate actions to mitigate Risks to an acceptable level.

- Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.

- Positively react to changes and show agile behaviour e.g. dealing with different quality levels to support fit for purpose quality in an RD environment.

- Excellent verbal and written communication skills to negotiate and communicate with internal and external customers.

Education / Experience

- University Master s degree or equivalent through experience, scientific orientation (pharmaceutical, chemical or biological sciences)

- At least 8-10 years experience in pharmaceutical industry (laboratory environment, analytical development)

- Language proficiency

- Fluent both in speaking and writing of English.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Role: Quality Manager / Supervisor,

Industry Type: Pharmaceutical & Life Sciences,

Department: Quality Assurance,

Employment Type: Full Time, Permanent

Role Category: Business Process Quality

Education

UG: Any Graduate

PG: Any Postgraduate read more

Key Skills agileaianalytical developmentanalyticsauditscgmpchange controlclinical trialscommunication skillscompliancecompliance managementcontractordocument managementhealthcareiso 9001manager qualitymanufacturing

📌 Manager Quality Assurance (Mumbai)
🏢 Johnson u0026 Johnson
📍 Mumbai