Head of Quality Management Systems

Job Description

Job Overview:The Head of Quality Management System is a leadership role within the Quality Operations function and will be responsible for the overall governance and integration of Quality Systems so as the ensure that a robust, sustainable, and effective quality management systems is in place at site.

• Acts as a strategic driver to implement the overall quality strategy within scope.
• Evaluates operations from a strategic level to ensure that systems consistently meet quality and regulatory requirements.
• Responsible for management of product technical complaints and associated investigation.
• Responsible to manage and coordinate, voluntary and mock recall activities as per process.
• Responsible for supplier lifecycle certification including supplier approval and audits.
• Manage site inspection readiness and commitment to audit and inspection action plans.
• Manage quality and product alerts and ensures appropriate escalation of critical quality events.
• Responsible to oversee effective change management systems at site.
• Responsible for document life cycle management at site.
• Responsible to oversee investigation closure and effective CAPA management.
• Manages the deployment and integration of Quality Risk Management principles into Quality Systems.
• Essential knowledge on Sterility Assurance principles, standards, and processes.
• Essential knowledge on validation and qualification principles, standards, and processes.
• Monitor continued compliance and drive the updates of policies and procedures with changing regulatory requirements
• Management and reporting of quality key performance indicators KPIs for the site.
• Manage and coordinate site quality review with senior leadership team and members to share the updates on site quality KPIs and Quality Projects.
• Lead the digitalization projects within perimeter and support in deployment of new systems to drive digitalization the quality management systems at site
• Management of Site Quality Roadmap to ensure that identified projects are timely executed
• Monitoring of site quality maturity index QMI with ongoing and continuous improvement of quality systems at site.
• Participate in Product Portfolio Management to align with Business Strategy.
• Develop budgets and monitor expenditures for Quality Management Systems.
• Strong Project Management skills and ability to design, manage and deliver projects.

• Effective communication with cross functional departments on quality topics.
• Excellent verbal and written communication skills with the ability to train staff.
• Responsible for development of team through trainings, coaching and constructive feedback.
• Responsible for talent management and succession planning for QMS function.
• Well versed with all applicable local regulations including but not limited to:

• DRAP Act 2012 and Drugs Act 1976
• Drugs Licensing Registering and Advertising Rules 1976
• The Drugs Labelling and Packaging Rules 1986
• Schedule B-II Current Good Manufacturing Practices
• The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976
• Drugs Specification Rules 1978
• Sindh Drugs Rules 1979

Education:

• Pharmacist (Pharm. D / B. Pharm)
• M. Sc. (Chemistry, Microbiology, Biochemistry)
• Additional degree in Business Management will be preferred.

Lead competencies:Well versed with all applicable local regulations including but not limited to the following:

• Act for Change
• Cooperate Transversally
• Develop People

Experience:

• Around 10 years of relevant experience of working in Quality Operations
• Relevant experience in a supervisory role of leading a team in a matrix organization.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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