DGM - R&D Quality. GCP QA

Sun Pharmaceuticals, Inc; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

A leading global pharmaceutical company is seeking a DGM - R&D Quality with extensive experience in GCP and Quality Assurance. This role involves implementing GCP requirements, supervising audits, and coordinating regulatory inspections. The ideal candidate will have over 15 years of experience in the GCP environment, with at least 8-10 years in Quality Assurance. Join us to contribute to our mission of fostering growth and compliance in clinical research.

Benefits

Robust benefits

Opportunities for personal and professional growth

Qualifications

• At least 15+ years of experience in GCP environment with 8-10 years in Quality Assurance.
• Experience of implementing GCP Quality programs and conducting GCP audits.
• Ability to lead, manage and motivate people with a variety of skill sets.

Responsibilities

• Implement GCP requirements according to regulatory guidelines.
• Supervise and execute R&D GCP QA program ensuring compliance.
• Plan and perform audits of bio-equivalence studies.
• Support and coordinate regulatory inspections.
• Monitor and review SOPs and documents for compliance.
• Create Training Plan for site R&D Quality-GCP QA team.
• Mentor and coach staff and manage performance issues.
• Develop team budget and manage expenditures.

Skills

Leadership

Understanding of GCP regulations

Auditing skills

Training and mentoring

Education

M. Pharm / B. Pharm - post graduate degree in basic sciences

Job description

Job Title: DGM - R&D Quality. GCP QA

Business Unit: Global Quality & Compliance

Job Grade G8

Location : Baroda

At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.

Key responsibilities

• Implement GCP requirements as per National & International regulatory guidelines / regulations for conducting BA/BE and Phase-I studies at Pharmacokinetic Department (PKD) through implementation of robust Quality Assurance (QA) program.
• Supervise, monitor and execute R&D GCP QA program at Vadodara to ensure compliance as per GxP and regulatory requirements for in-house and outsourced BA/BE studies (conducted in patients and/or in healthy volunteers).
• Plan, supervise, monitor and perform audits like in-process audits, retrospective audits system/facility/process-based audits of in-house and outsourced bio-equivalence studies in order to identify gaps and areas of improvement for compliance to regulatory requirements. Supervise creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards.
• Plan and conduct/ supervise qualification/ requalification audits of Contract Research Organizations (CROs), Contract Service Providers (CSPs)/ Material Suppliers.
• Verify adequacy of created CAPA plans.
• Support and coordinate regulatory inspections, review of regulatory response and reply to regulatory inspection queries/observations in a time bound manner. Support implementation of appropriate CAPA for the identified gaps.
• Monitor, supervise and review SOPs, ATPs, study protocols, instrument qualification, incidents, investigations and change control documents.
• Evaluate current systems and processes and create/revise and implement new/revised Standard Operating Procedures (SOPs) and global documents, as required, in collaboration with relevant stakeholders at R&D. Harmonize systems and processes with other GCP sites, as applicable.
• Ensure departmental Management Review Meetings (MRMs) are arranged and conducted on time to evaluate quality and compliance status and action items agreed are reviewed periodically.
• Issue Quality Assurance Audit Statement/Certificate as per applicable requirements.
• Monitor overall Quality Management System of GxP functions at site.
• Create Training Plan for site R&D Quality-GCP QA team. Ensure necessary training is imparted to new joinees and existing staff and assessment of training is conducted in a timely manner. Impart or assist in imparting training and monitor training program for R&D Quality - GCP staff for applicable guidelines, regulations, best practices etc.
• Mentor and coach both the direct and, as appropriate, indirect reports through ongoing example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner.
• Develop team expenses, capital budget and head projections. Track and manage expenditure and headcount to budget over the fiscal year.

Travel Estimate

Job Requirements

Educational Qualification

M. Pharm / B. Pharm - post graduate degree in basic sciences with at-least 15+ years of experience in GCP environment of which at least 08-10 years experience must be in Quality Assurance.

Experience

High level of understanding of local and international GCP regulations and clinical research processes including outsourced studies. Experience of implementing GCP Quality programs and conducting GCP audits. Experience of qualification of CROs/CSPs/ Material suppliers. Experience of conducting internal and external audits. Experience in handling regulatory agency inspections at sites. Excellent auditing skills. Ability to lead, manage and motivate people with a variety of skill sets. Good knowledge of IT/computer systems.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.