Quality Assurance Associate Manager - Life Sciences

Accenture India Private Limited; Bengaluru; On-site; INR 3,000,000 - 4,500,000; Full time

Job summary

Accenture is seeking a Quality Assurance Associate Manager with 12–14 years of QA governance, operations and regulatory experience. The role focuses on audits, compliance, and ensuring quality across the life sciences services portfolio.

The candidate will align with Life Sciences R&D offerings, supporting processes from documentation control to CAPA management and regulatory readiness in a global delivery framework.

Qualifications

• BSc/Bachelor of Pharmacy/Bachelor Degree in Life Sciences required.
• 12–14 years of experience in QA governance, audits and compliance.
• Experience in clinical/pharma regulatory environments preferred.

Responsibilities

• Support Clinical Quality Assurance roles and responsibilities as SME.
• Review project records, onboarding/offboarding, training docs, governance decks and CAPA evidences.
• Perform process risk assessments and track actions to closure.
• Conduct training for new hires and revised courses.
• Provide monthly inputs for inspection readiness and IR status.
• Assist in audits/inspections and manage logistics for client/internal audits.
• Ensure CDP controls and pharma IT controls are updated; support 100% compliance.

Skills

Quality Governance

Operations Management

Regulatory Compliance

Education

BSc

Bachelor of Pharmacy

Bachelor Degree in Life Sciences

Job description

Quality Assurance Associate Manager Skill required: Quality Governance & Operations - Operational Audit & Compliance Designation: Quality Assurance Associate Manager Qualifications: BSc/Bachelor of Pharmacy/Bachelor Degree in Life Sciences Years of Experience: 12 to 14 years

About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

Quality Governance & Operations involves establishing and maintaining standards and processes to ensure the quality of products or services. This includes setting quality policies, conducting audits, and monitoring compliance with regulations. The goal is to create a consistent and reliable framework for quality management. Effective quality governance helps in minimizing risks, improving performance, and ensuring customer satisfaction. It is essential for maintaining the integrity and reputation of an organization.

Audit and manage effective implementation and delivery of functional processes within operations to mitigate risk. e.g. Policies; Anticorruption, BCM, InfoSec, P104, Records Management and Contractor controls. Establish processes to audit/validate current control effectiveness and drive improvements wherever required.

What are we looking for? Support as an SME for Clinical Quality Assurance Roles and Responsibilities:

• Review compliance to project specific requirements for maintaining records/documents, viz., hard copy and/or soft copy of onboarding, off boarding, training records, Organogram, Members List, Project access control records, JD, CV, HOTO forms, list of essential documents, minutes of meetings, governance decks, audit CAPA and its evidences, Pharma IT Controls list, CSV compliance of all tools, list of SOP/SWI, controlled copies of project specific SWIs etc.
• Perform process risk assessments of the assigned projects as needed. Identify actions and track them to closure.
• Perform process level checks using approved checklists and submit all reports on time.
• Conduct relevant training for new hires / any revised courses / awareness trainings as applicable
• Provide monthly inputs for inspection readiness in IR tool. Track and update status of IR action items.
• Provide support during audits/ Inspections and manage the logistics for client and internal audits.
• Provide guidance and review all deviations/CAPA, provide support in RCA and submit relevant documents and evidence to QA team.
• Ensure all applicable CDP controls are updated on an ongoing basis. Perform monthly Pharma IT control checks.
• Provide support for the Operations team to achieve 100% compliance with tasks as per client requirement.
• Engage in CSV compliance activities at Engagement and Pharma level, as applicable