11 Oct
Kashiv BioSciences
Ahmedabad
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Job Type
Full-time
Description
Must apply / send resume directly to : are seeking a highly skilled and experienced individual to fill the role of Head of Quality Assurance
and Compliance within our Biopharmaceutical company. The successful candidate will be responsible
for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects
of our operations. Reporting directly to the executive leadership team, the Head of Quality Assurance
and Compliance will play a critical role in maintaining and enhancing our reputation for excellence in
the industry.
1.Establish and Maintain Quality Systems : Develop and maintain robust Quality Systems to
support cGMP activities,
ensuring compliance with regulatory requirements and industry
standards.
2. Manage Quality Control and Assurance Departments : Direct and oversee the activities of the
Quality Control and Quality Assurance departments, ensuring efficient and effective operation.
3. Oversee Document Control and Training Systems : Provide oversight of document control and
training systems management, ensuring accurate documentation and effective training of
personnel.
4. Demonstrate Regulatory Expertise : Demonstrate strong knowledge of cGMP, Quality Systems,
and regulatory guidance, providing expertise and guidance to ensure compliance in areas such
as Qualification and Validation processes, clinical trials, and BLA submissions.
5. Direct Quality Operations Activities : Lead Quality Operations activities for product disposition,
ensuring final approval for market release in compliance with regulatory requirements.
6. Lead Cross-Functional Teams : Lead cross-functional teams to resolve quality issues, implement
necessary Corrective and Preventive Actions (CAPAs), and drive continuous improvement
initiatives.
7. Vendor Management Collaboration : Collaborate with Vendor Management to ensure vendor
quality requirements are met, maintaining effective relationships with key suppliers and
partners.
8. Drive Continuous Improvement : Collaborate with technical operations teams and company
leadership to drive continuous improvement programs aimed at enhancing product quality,
operational efficiency, and compliance.
9. Supervise QA and QC Managers : Supervise Quality Assurance and Quality Control managers,
including performance management, planning, and conducting performance reviews.
Prepare for and Manage Regulatory Inspections : Prepare for and manage regulatory agency
inspections, ensuring readiness and facilitating successful outcomes.
- Recruit, Develop, and Retain Quality Personnel : Recruit, develop
- Provide Performance Feedback : Provide formal and informal performance feedback to direct
and indirect reports, making decisions on employee development, promotions, and salary
increases.
Ensure Compliance and Oversight : Ensure compliance with all company policies and standards,
providing oversight of key quality documents generation and review.
Global Collaboration : Plan and direct resources and activities of quality and compliance
functions globally, collaborating with quality staff in other company locations worldwide.
Culture of Compliance and Continuous Improvement :
Establish and promote a culture of
compliance and continuous improvement throughout the organization, supporting and guiding
Quality Management Systems for continual enhancement.
Lead Quality Responses and Initiatives : Lead Quality responses for information requests and
business development proposals, identify and lead process improvement initiatives related to
quality.
Technical Liaison and Training : Ensure technical liaison between Quality and other functional
groups, plan, promote, and organize training activities related to quality and compliance,
coordinating with Learning & Development.
Regulatory Knowledge and Compliance : Maintain knowledge of FDA, EU, MHRA, & EMA
regulations and standards, ensuring compliance across all activities.
CAPA and Complaint Management : Maintain robust Corrective and Preventive Action (CAPA),
nonconformance, and complaint management systems, ensuring timely and effective
resolution.
Travel and Other Duties : Travel up to %, including international travel, and perform other
duties as assigned.
Requirements
Qualifications
- Bachelor's degree in pharmacy, biology, chemistry, or a related field; advanced degree Master's, PhD) preferred.
- Certification in quality management ASQ Certified Quality Manager, Six Sigma Black Belt) preferred.
Experience
- In-depth knowledge of biopharmaceutical manufacturing processes, including upstream and downstream operations, purification, and analytical testing techniques.
- Strong understanding of regulatory requirements governing biopharmaceutical manufacturing, including FDA, EMA, and ICH guidelines.
- Excellent leadership, communication, and interpersonal skills, with the ability to collaborate effectively across functions and influence decision-making at all levels of the organization.
- Demonstrated experience in leading and managing teams, fostering a culture of continuous improvement, and driving operational excellence.
- Highly organized, detail-oriented, and analytical, with the ability to prioritize tasks, manage multiple projects simultaneously, and drive results in a fast-paced environment.
30+ days ago
▶️ Head – QA
🖊️ Kashiv BioSciences
📍 Ahmedabad