Company Overview

Recruitment.

Job Description

We have the following career opportunity with one of our Pharma / Biotech client: Job Title: Head of Quality Operations – Vaccines & Biological Industry Location: Bhubaneswar Reports to: Site Head or VP of Quality Position Summary: The Head of Quality Operations oversees all quality-related functions in a vaccines and biological manufacturing environment, including Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, and Compliance. This leader ensures that products meet the highest standards of quality and compliance with international regulatory requirements. The role includes responsibility for IPQA, batch release, QMS, DMS, LIMS, digitalization of quality processes, as well as microbiology, virology, chemical testing, EHS, animal facility management, and method validations. The ideal candidate brings 20+ years of experience in injectable, biological, or vaccine manufacturing and possesses deep expertise in regulatory audits, risk assessment, and vendor qualification. Key Responsibilities: • Quality Assurance & Compliance: o Oversee in-process quality assurance (IPQA), batch release activities, and ensure compliance with GMP, WHO, CDSCO, EMA, and USFDA standards. o Develop, implement, and maintain a robust Quality Management System (QMS) to ensure all operations meet regulatory and industry standards. o Lead and manage documentation control through Document Management System (DMS), Laboratory Information Management System (LIMS), and digital quality systems to support data integrity and operational efficiency. o Establish and enforce audit and compliance programs, including vendor audits, self-inspections, and adherence to global regulatory standards. • Regulatory Affairs & Batch Release: o Ensure timely batch release and regulatory submissions, managing all aspects of regulatory affairs and compliance with relevant health authorities. o Prepare and manage regulatory documentation for product licenses, amendments, and renewals, facilitating compliance with international regulatory bodies. o Coordinate with cross-functional teams to support regulatory inspections and audit readiness. • Quality Control (QC) & Lab Compliance: o Oversee QC activities including microbiology, virology, chemical testing, and EHS compliance to ensure product safety, potency, and purity. o Manage and ensure compliance within QC laboratories, including method validation, equipment calibration, lab documentation, and adherence to GLP. o Supervise the animal facility for any necessary testing, ensuring ethical standards and regulatory compliance. o Lead initiatives to continuously improve lab operations, including the adoption of digital tools and automation for increased efficiency and data integrity. • Risk Assessment, APQR, and Continuous Improvement: o Lead annual product quality reviews (APQR), ensuring thorough analysis and documentation of product quality trends, deviations, and risk assessments. o Conduct and oversee risk assessment activities to identify, document, and mitigate potential quality and compliance risks across production processes. o Drive continuous improvement initiatives in quality systems, implementing best practices, and fostering a culture of quality excellence. • Audit Management & Inspection Readiness: o Ensure readiness for regulatory audits, including preparation, management, and follow-up for inspections by WHO, CDSCO, EMA, USFDA, and other regulatory agencies. o Develop and implement internal audit programs and oversee vendor qualification and requalification processes to ensure supplier compliance. o Address audit findings and implement corrective and preventive actions (CAPA), ensuring a state of perpetual audit readiness. • Digitalization of Quality Processes: o Lead the digital transformation of quality processes, implementing LIMS, QMS, and other digital tools to enhance data integrity, traceability, and operational efficiency. o Drive initiatives to integrate digital solutions within QA and QC functions, supporting data analytics, remote monitoring, and paperless documentation. • Leadership & Team Development: o Build, lead, and mentor a high-performing quality team, fostering a culture of accountability, integrity, and continuous improvement. o Establish clear goals, performance metrics, and professional development plans to enhance team capabilities and support career growth within the quality organization. o Promote cross-functional collaboration with Production, R&D, and Regulatory Affairs to support overall operational success. Qualifications: • Education: Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmacy, or related field. Advanced degrees or certifications in Quality Management or Regulatory Affairs are a plus. • Experience: o 20+ years of experience in Quality Assurance, Quality Control, and Regulatory Affairs within injectable, biological, or vaccine manufacturing. o Extensive experience with regulatory inspections and audits, particularly with WHO, CDSCO, EMA, and USFDA standards. o Proven track record in managing IPQA, QMS, batch release, risk assessment, and lab compliance in a GMP-regulated environment. • Technical Knowledge: o Strong understanding of microbiology, virology, chemical testing, and EHS requirements for vaccine manufacturing. o In-depth knowledge of GMP regulatory standards, documentation control, APQR, and validation protocols. o Proficiency with DMS, LIMS, EMS, and other digital systems for quality management and lab compliance. • Regulatory & Audit Skills: Extensive experience in preparing for and managing regulatory inspections, vendor audits, and CAPA implementation. • Leadership & Interpersonal Skills: Proven leadership in managing cross-functional quality teams and fostering a culture of compliance, continuous improvement, and innovation. • Analytical & Problem-solving Skills: Strong analytical skills to drive data-driven decisions, conduct root-cause analysis, and improve quality operations. This role provides an opportunity for a quality leader to make a significant impact on the integrity, compliance, and success of a vaccine manufacturing facility, ensuring that all quality operations meet the highest standards of safety and efficacy. .

Required Exp

Above 20 years yrs

Skill Required

The Head of Quality Operations oversees all quality-related functions in a vaccines and biological manufacturing environment, including Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, and Compliance. This leader ensures that products mee

Job Location

Bhuvaneshwar, India

Salary Package

$ 50LPA

Date of Job Posting

2024-12-06 14:36:59

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