Quality Assurance Associate Manager

Accenture; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Accenture is looking for a Quality Assurance Associate Manager to oversee quality governance operations within the Life Sciences RD vertical. The role involves developing quality management frameworks, leading compliance activities, and managing client audits. Ideal candidates should have 10 to 14 years' experience with relevant qualifications in Pharmacy or Dental Surgery. The position entails significant responsibilities in ensuring product quality and compliance and may require rotational shifts.

Qualifications

• 10 to 14 years of experience in Quality Governance Operations.
• Strong understanding of strategic direction set by senior management.
• Ability to lead and manage quality and compliance activities.

Responsibilities

• Create and implement a Portfolio Quality Management framework.
• Lead client audits and inspections by regulatory authorities.
• Drive standardization of processes and systems across projects.
• Ensure effective management of deviations and CAPAs.

Skills

Quality Governance Operations

Operational Audit Compliance

Risk Management

Client Audits and Inspections

Education

Bachelor of Dental Surgery/Bachelor of Pharmacy/Master of Pharmacy

Job description

Skill required: Quality Governance Operations - Operational Audit Compliance

Designation: Quality Assurance Associate Manager

Qualifications: Bachelor of Dental Surgery/Bachelor of Pharmacy/Master of Pharmacy

Years of Experience: 10 to 14 years

What would you do

You will be aligned with our Life Sciences RD 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 worlds 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.

Responsibilities and Authorities

• Creation and implementation of Portfolio Quality Management framework for the assigned LS RD engagement.
• Establish quality and compliance activities for existing and new scope of services.
• Lead and act as the point of contact for client audits and inspections by regulatory authorities.
• Lead/contribute to the creation of formal processes; review and approve them as applicable.
• Assume overall document management responsibility for the assigned project.
• Ensure data security and privacy measures are implemented across deal teams, delivery leads, and representatives.
• Lead Quality Governance meetings with clients, share compliance metrics, assign action items, and track them to closure.
• Ensure deviations and CAPAs are managed effectively and closed on time.
• Monitor and contribute to contract updates and ensure process changes are implemented and tracked.
• Drive standardization of processes and systems across project locations.
• Lead execution of audit/inspection recommendations and maintain evidence of completion.
• Develop and execute deliverables in the Quality Management Plan in line with contract requirements.
• Identify role-based training needs.

Role Expectations

In this role you are required to analyze and solve moderately complex problems, typically creating new solutions, leveraging and, where needed, adapting existing methods and procedures. The person requires understanding of the strategic direction set by senior management as it relates to team goals. Primary upward interaction is with direct supervisor or team leads. Generally interacts with peers and/or management levels at a client and/or within Accenture. The person should require minimal guidance when determining methods and procedures on new assignments. Decisions often impact the team in which they reside and occasionally impact other teams. Individuals would manage medium-small sized teams and/or work efforts if in an individual contributor role at a client or within Accenture. Please note that this role may require you to work in rotational shifts.