Accenture - General Manager - Risk & Compliance QA - Pharma/Clinical Domain

Job Title: R&C Pharma QA Manager

Role: Risk and Compliance

Location: Bangalore

Overall Purpose of the job

Develops and manages quality programs to promote and monitor the quality and performance of Accenture operations as they relate to clinical trials and overall compliance with Accenture and Customer procedures and policies as well as with regulatory requirements.

Responsibilities/Authorities

- Strategize, manage and oversee established QA programs, assist other QA Staff and Accenture Senior Management in the development of new and improved programs to ensure that Accenture's services and products meet quality standards, and manage and oversee the day-to-day workload for QA Staff.

- Ensure that all projects have QA representation. Ensure that adequate resources are assigned to projects for document reviews and audits. Ensure that findings are documented, discussed with appropriate personnel, and resolved properly.

- Perform analysis of processes. Review Accenture processes (e.g., policies, standard operating procedures, guidance documents), discuss with other QA Staff, Accenture Senior Management, and other appropriate Accenture Staff, and manage and oversee the development, administration, and training of new and revised processes. Provide sign-off on policies and SOPs.

- Strategize, manage and oversee the audit program of Pharma QA team. Ensure Accenture is prepared for Customer audits and regulatory agency inspections.

- Provide guidance to QA Staff and project on related quality and compliance issues, discuss problems with other QA Staff and Accenture Senior Management, and respond back to QA Staff and project with resolutions.

- Manage and oversee the training, mentoring, and career development of QA Staff.

- Assist Accenture Senior Management in the development of new programs and business and the development and presentation of materials to Customers or at meetings.

- Strategize, work along and contribute to the Global R&C team processes and programs

- Take instruction and perform tasks as necessary as directed by reporting manager.

- Perform document reviews (e.g., study reports, tables, listings, policies, standard operating procedures, guidance documents, computer validation documents). Document findings, discuss issues with other QA Staff, QA Management, and the Project Manager or designee, and provide QA approval after proper resolution.

- Conduct internal audits (e.g., data, file, processes/systems, adherence to SOPs/project specifications, use of tracking systems, on-time deliverables). Document findings, discuss issues with other QA Staff, QA Management and the Project Manager or designee, prepare audit reports, and ensure proper resolution of issues.

- Assist in the collection and dissemination of relevant/requested GCP information and provide training. Should be available at any time to assist in performing project activities or to serve as a back-up to other QA Staff. Perform other duties as assigned or as necessary as business dictates.

- Perform Computer System Validation of the tools developed by Accenture.

- Planning and implementation of validation processes on various applications as per FDA 21 CFR regulations, ISO 13485 to ensure system compliance with the regulatory requirements and quality.

Educational and Experience Requirements - 

- Bachelor's Degree and/or a minimum of 12+ year's related industry experience with a strong emphasis in Quality Assurance.

- Must have an excellent understanding of the conduct of clinical trials, clinical trial-related systems and procedures, the nature of the drugs being studied, and applicable regulations. Must have proficiency in performing document reviews and conducting audits. Must have the ability to analyze systems and procedures.

- Must have demonstrated experience in developing and administering Quality Assurance Auditor and company compliance training programs.

- Must have demonstrable supervisory experience. Must have excellent verbal and written communication skills and excellent people skills (Customer oriented). Must have the ability to relate on a professional level with QA Management, internal Customers, Project Managers or their designees, and Customers. Must have prior experience in communicating and interacting with internal and external Customers.