SGM/AVP - Quality - Small Molecules

Hiring for SGM/AVP Quality - Small Molecules

Location: Bangalore

Experience: 20-25 yrs

The Role

The Head Quality, Small Molecule will Design, Develop, and maintain quality systems to ensure patient safety and compliance to cGMP and applicable regulations for small molecules of drug substances and drug products.

This role reports to the Chief Quality Officer of Corporate Quality Assurance. As a member of the Quality Assurance Leadership Team, the role shares responsibility along with the key stakeholders of Development & Manufacturing services in providing Quality oversite for GMP quality operations.

Key Result Areas

Role-specific:

- Manage and provide quality oversite for GMP quality operations, including reviewing batch records for manufacturing and labeling/packaging operations and timely batch release. Review and approve applicable GMP documentation such as analytical test Methods, Method validation protocols, reports, stability data, product specifications, and change controls.

- Ensure products are manufactured and tested. and dispositioned in compliance with SOPs and applicable regulations.

- lnterface with stakeholders to ensure timely closure of deviations, OOS, investigations, CAPA, provide technical review and inputs for investigations related to deviations, OOS, OOT, and customer complaints.

- Lead all regulatory and client quality audits as applicable in the work area.

- Impart training on QMS systems, Investigations, GMP, data integrity, and good documentation practice.

- Support vendor qualification and oversight process

- Establish and maintain quality agreements with all clients.

- Interact with clients, including their quality contacts as per requirements.

- Interact with regulatory agency and Government authority for any query resolution related to small molecules and stability center.

- Communicating with Regulatory Agencies, Customers / Clients, Government Authorities etc. for updates, notifications, response to queries/observations and clarifications as relevant to Small Molecule.

- Establish and maintain quality assurance policies and procedures and controls to meet quality and regulatory requirements.

- Establish and maintain quality control systems for small molecule vertical.

- Develop and implement quality metrics to drive continuous improvement.

- Ensure compliance of all software systems is in line with regulatory requirements in the business vertical.

- Responsible for reporting the health of the quality system to the chief quality officer.

- Improvement in the efficiency of quality reviews set key performance indicators and regular monitor/or progress.

- Build client relationships from a quality and compliance perspective. Identify and implement client satisfaction level.

- Evaluate and maintain resource requirements in line with operating units.

- Oversee implementation of safety program as mandate and initiated by EHSS.

- Achieve EHSS metrics and safety goals in collaboration with EHSS leadership.

- Ensure 100% adherence to safety requirements implemented in the organisation.

- Support corporate Quality Assurance and Internal audit and continual improvement functions of quality assurance for quality system enhancements.

- Participation and approval of facility, process and EHS risk assessment.

- Any other assignment as given by reporting manager.

As a leader:

- Champion effective Environment, Occupational Health, Safety, and Sustainability (EHSS) practices for

the company, and oversee compliance with those practices within the Quality team. Play an active leadership role in monitoring and verifying safety performance through GEMBA walks and other safety-led activities.

- Foster a corporate culture that promotes an environment, occupational health, safety and sustainability(EHSS) mindset as well as the highest standards of quality, integrity and compliance.

- Put people at the heart of company's success by providing clear, active leadership defined by the organization leadership framework setting high standards of people management, career planning, and talent retention as a priority.

Education and Experience

Education

- MSc/BPharma/MPharma/PhD in life sciences from an internationally reputed university.

Industry Experience

- Minimum 15-20 years of relevant practical and leadership experience in Quality Assurance (Pharma, CDMO).

People leadership experience

- Proven ability in leading, developing and managing direct staff and cross functional teams upwards of 200-

- 300 people in a matrixed, multi-cultural, and multinational environment.

- International exposure and experience

- Current/Prior experience of working in regulated markets would be preferred.

Other competencies required for the role

- Excellent people skills with extensive experience in leading change, and a proven ability to instill a culture of collaboration.

- Rich & Diverse experience in API/Formulation QA

- Keen interest in scientific innovation in a commercial setting.

- Strong customer and service delivery mindset with a proven track record in delivering business growth.

- High degree of results orientation with a track record of growth and delivering against targets.

- Well networked and strong industry knowledge.

- Confident and well-practiced language and interpersonal skills

- Impeccable ethics and integrity along with an exposure to a multi-cultural work environment.

Interested Candidates can contact:

Shalu Bajaj

8200113377