CMO Quality Head

Position: CMO Quality Head (India CMO and US CMO)

Department: Corporate Quality

Location: Mumbai/ Vadodara

Grade: G7- GM

Reporting Manager Title: Quality Cluster II, III & EM Head

Classification: CMO Quality

Job Summary:

Provide strong leadership & Lead CMO Quality operations for India CMO and US CMO. India CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for India, ROW, EM markets through various business model like LL, P2P, In-licensing. US CMO includes QA oversight for all contract mfg. sites based in India and engaged in mfg. SUN products for US market through various business model like LL.

Essential Job Functions:

1. To ensure availability and periodic revision of quality agreements (QAg) between SUN Pharma & CMO sites.

2. To ensure product quality complaints, quality alerts, FAR, recalls etc. are being handled timely and inline with QAg.

3. To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities' requirements are met and CMOs maintain and improve the adequate level of compliance, through CMO oversight.

4. Proactively assess quality issues and ensure compliance to QA/QC regulatory requirements in manufacturing operations at CMO sites.

5. Prevent Quality or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Ensure that Non-compliance are to be addressed via robust investigation & corrective and preventive actions (CAPA).

6. Accountable for implementing and ensuring compliance to applicable Global SOPs, Policies, Standards and Quality systems at CMO oversight function.

7. Responsible for CMO Quality functions lean design and execution of continuous Quality & Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance and drive efficiencies.

8. Facilitate new product launch and technology transfer activities (Sun site & R&D) and ensure timely execution of related activities.

9. Drive annual risk assessment of CMO sites (India and US market), review the outcome, identify high risk sites/products and ensure remediation plan is in place either by de-risking of manufacturing sites or product manufactured therein.

10. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals at CMO oversight function.

11. Responsible for ensuring smooth collaboration with Sun sites, commercial, RA, R&D, MSTG, corporate quality audit & CMO sites for activities related to product manufacturing, release and other quality & technical issues to leverage synergies.

12. Monitor and utilize industry trends, internal learnings and new regulatory requirements to Identify and upgrade quality management system, facility and processes to ensure compliance at CMO sites as applicable.

13. Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.

14. Periodic visit of high risk CMO sites to ensure quality and compliance of the sites.

15. Will perform other work-related duties, as required.

Requirements and Qualifications:

Basic Qualification:

• M.Sc./ B. Pharm / M. Pharm or equivalent.

Industrial Experience & Knowledge:

• Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in OSD and / or sterile formulations manufacturing.

• Exposure to various formulations like sterile, ophthalmic, aerosols, Creams, Ointments, Oral Liquids, Nutraceutical, capsules (Hard and Soft Gelatin) and tablets will be preferred.

• Knowledge of GMP's in FDA, Domestic and international regulatory environments. In-depth knowledge of FDA guidance's such as ICH is must.

• Strong organizational, interpersonal and communication skills.

• Ability to work effectively in multicultural matrix organization.