Head of Quality Operations
Head of Quality Operations
Posted on :
30-11-2024
Employer Active
1 Vacancy
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Job Description
The Head of Quality Operations oversees all qualityrelated functions in 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. The ideal candidate brings 20 years of experience in regulatory audits risk assessment and
vendor qualification.
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. The ideal candidate brings 20 years of experience in regulatory audits risk assessment and
vendor qualification.
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 crossfunctional teams to support regulatory inspections and audit readiness.
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 crossfunctional teams to support regulatory inspections and audit readiness.
Audit Management & Inspection Readiness:
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.
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.
Leadership & Team Development:
o Build lead and mentor a highperforming 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 crossfunctional collaboration with Production R&D and Regulatory Affairs to support
overall operational success.
o Build lead and mentor a highperforming 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 crossfunctional collaboration with Production R&D and Regulatory Affairs to support
overall operational success.
Employment Type
Full Time
Key Skills
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