Manager Quality Assurance

Overview

QA Manager for the Clinical Supply Quality Laboratories team within Johnson & Johnson's Clinical Supply Quality (CSQ) department, providing quality oversight and compliance support for the Higi synthetics laboratories and their contract laboratories.

What you'll do

• Support, coach and develop the team in reaching quality, business and personal objectives.
• Ensure quality oversight on the TDS Synthetics Higi laboratories and their contract laboratories.
• Connect and develop strong relationships with quality and business partners and stakeholders to address issues and opportunities.
• Proactively and continuously challenge organizational performance and develop and implement improvements.
• Ensure GMP activities in the laboratories and contractor laboratories comply with IMP regulations and national and international cGMP requirements.
• Organize and host quality meetings such as CPA Board and QIP, and prepare and support QSMR meetings.
• Organize, prepare and support 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 supporting development projects, in line with global J&J policies, IMP regulations and cGMP requirements.
• Ensure events, deviations and CAPAs are evaluated and approved on time, with records meeting quality and compliance requirements and adequate corrective and preventive actions taken.
• Review and approve procedures and documents for analytical and microbiological activities.
• Manage external audits from health authorities and customers, support or execute internal audits, and conduct check rounds to monitor laboratory compliance and process performance.
• Review and approve quality investigations and change controls, and provide quality metrics for quality reporting.

What you'll need

• University Master's degree or equivalent through experience, with scientific orientation (pharmaceutical, chemical or biological sciences).
• At least 8-10 years' experience in the pharmaceutical industry (laboratory environment, analytical development).
• Leadership and decision-making skills to meet business objectives in 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, including 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 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, modalities, techniques and product types.
• Clear understanding of, and ability to perform, risk assessment and develop/provide appropriate actions to mitigate risks to an acceptable level.
• Positively react to changes and show agile behaviour, e.g. dealing with different quality levels to support fit-for-purpose quality in an R&D environment.
• Excellent verbal and written communication skills to negotiate and communicate with internal and external customers.
• Fluent in speaking and writing English.
• IT proficiency in applications supporting quality processes (e.g. NC/CPA, change control, training, document management) and MS Office suite.

Nice to have

• Experience with regulatory inspections as spokesperson, in a backroom role, or in inspection preparation.

Details

• Location: Mumbai, Maharashtra, India.