Job Description
In this role, you work from the Asia Pacific region, manage the Asia Pacific unit of GCA providing auditing, audit program management, and compliance management and inspection management services for all Novartis companies. This, to ensure consistent regulatory compliance and product quality. The position is to be based out of Singapore.Key accountabilities:
• Lead the Asia Pac group of Group GxP Compliance & auditing, responsible for GxP Compliance auditing and support, and management of the Group GxP Audit Programme.
• Evaluate and approve global GxP audit plans in collaboration the GCA Head and GCA Group Heads and with the divisions.
• Plan and Conduct pre-approval/pre-submission project reviews, “mock” pre-approval inspections. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
• Prepare organization and provide on site support for key GMP, GCP, GLP and Pharmacovigilance health authority inspections, input to responses and corrective action plans to ensure consistency and appropriateness of commitments, in collaboration with Site and Divisional QA units.
• Review and approve, in collaboration with the responsible quality units and auditors, proposed corrective/preventative action plans. Monitor progress to completion, in collaboration with Divisional QA.
• Interact with health authority representatives on compliance or quality related matters, in collaboration with the Head of GCA.
• Perform and document regulatory compliance assessments of strategic operations within the Novartis organizations, divisions and business units, in accordance with the standards defined in the Novartis Quality Manual and national/international GxP requirements.
• Ensure continuous development of the Novartis Quality Manual and the Audit Manual by providing feedback from audits and inspections on site-level effectiveness, participating in the Module rolling review process, preparing module updates, and performing final reviews.
• Provide support for the Novartis Group Auditor Certification Programme and Audit Manual according to own areas of expertise, through development of training material, and workshops/presentations.
• Participate in Group and Divisional quality management/ remediation projects, providing support, and for personal skills development, as directed.
• Develop and propose global corrective action plans, where identified as a potential systemic gap, for the GxP governance boards. Propose updates of the Novartis Global Quality Systems, where indicated. Participate in the development of Corporate Quality Modules and Implementation Guidelines.
• Provide consultant services for quality, compliance and remediation strategies, and input to key quality policy decisions to drive business decisions impacting quality, safety or compliance.
• Manage Asia Pacific Group personnel including objective setting and performance assessments
• Ensure continuous development of group personnel via training, delegation of developmental duties and responsibilities, and participation in technical and management projects.
• Mentor and train junior staff members on auditing/compliance management skills development.
• Prepare/contribute to operational team objectives as assigned.
• Deputize for group head, as assigned.
Desired Skills & Experience
Education and training:• Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
Languages:
• Excellent oral and written English communication skills.
• Second language is preferred
Experience:
• 10 years broad experience in Pharmaceutical Industry including in mid-size management functions, with international scope. Valid operational experience includes safety or clinical/pre-clinical operations, or QA/QC operations, quality management experience, development or other relevant experience working at a health authority. Broad business awareness required.
• Broad expertise in Compliance and Health Authority Interaction, across the GxPs and various businesses (medical device, veterinary, OTC, Generics and ethical pharmaceuticals). Detailed knowledge of GxP regulations.
• Working experience with quality engineering concepts/Risk management tools and modern technologies.
• Experience leading teams and projects, with excellent leadership, facilitation and organisational skills.
Travel:
• 40% minimum, international
Apply Now - Resume or CV with Job Post Title
Email: jobs@aarenconsultants.in
Subscribe to us
100% Free.
close