Director - Clinical Quality Assurance - Biopharmaceuticals

Role Purpose : The Director of Clinical Quality Assurance serves as a strategic quality resource in managing quality and regulatory compliance related to GCP, Pharmacovigilance (PV) and other related activities

Job Description

- Develop and implement QA infrastructure capable of supporting the GCPand PV

- Oversight of all quality assurance initiatives including management of quality and regulatory compliance related to GCP and PV activities

- Coordinates the revision, review, and approval of SOPs and other GxP documents.

- Organizes and ensures accurate and reliable filing systems for the paper-based GxP documents.

- Selects, evaluates, and implements electronic document processing and archiving systems.

- Ensure all systems, processes and their outcomes comply with applicable regulations and guidelines

- Represent the organization during customer visits. Provide support for all audits and inspections by customers and regulatory agencies if any

- Oversee GCP activities (including internal or external audit observations and development of CAPA) to ensure data integrity

- Provide QA oversight of computer system validations and change control

- Review Quality documentation to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement

- Review/revise/approve and implement SOPs to ensure the site compliance and GCP

- Perform periodic review to document and report gaps and risks

- Define and own the QA methodology

- Establish and maintain company policies relating to quality products and services

- Oversee work of direct reports and cross-train staff on different qualityareas. Interview, hire, train, develop and manage employees

Must Have Qualifications :

- Quality professional with min15 years of hands-on experience in QA in bio-pharmaceutical industry.

- In-depth Knowledge of GxP, QA best practices and regulatory guidelines

- Experienced in Documentation authoring and requirement analysis (min. 3 years)

- Experienced in Process engineering (desirable)

- Knowledge & Experience with electronic document management system.

- Well-organized and detailed oriented professional, with strong verbal and written communication skills.

- Must be self motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines.

- Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.

Experience :

- 15 plus year of experience in Quality Management

- Sound knowledge of Project and Quality Management methodologies like SDLC, reviews, and training

- Excellent understanding of complex quality landscapes and relationships (Quality Systems, Policies, IT QM)

- Leading and managing Global team directly