Head of Remediation, OSD Quality

Job Description

Purpose:

Provide leadership and be accountable to all Remediation activities across OSD Sites in India. Pan out the strategy, collaborating with cross functional teams ensuring overall compliance and quality of our products encompassing Remediation project management, Quality systems assessment and improvement, regulatory compliance, Investigations, documentation and reporting & Training and communication.

Key Responsibilities

• Lead and manage execution of all remediation activities for OSD sites in India, including CAPA actions for health authority observations, internal audit deficiencies and self-inspection observations.
• Manage project timelines, budgets and resources to ensure timely completion of remediation activities.
• Host health authority inspections and internal audits, when needed.
• Lead response management activities; draft responses to inspection observations, periodic updates and any other health authority communications.
• Represent the sites and provide status updates to senior leadership in remediation governance meetings, quality council and global/regional scorecard discussions.
• Ensure that site has adequate resources and tools necessary to execute against remediation plan deliverables.
• Escalate critical quality events to senior leadership; partner with other stakeholders such as Operations, R&D and Regulatory and provide timely resolution for critical quality events as appropriate.
• Assemble and file any field alert reports (FARs)/defect notification reports and support any associated market action activities, as necessary.
• Lead inspection readiness efforts at the site.
• Coordinate preparation and review of evidence binders for all remediation CAPAs.
• Track CAPA effectiveness activities.
• Provide other support, as needed.

Qualification, Experience, & Competencies:

• Masters in Pharmacy / MSc in Chemistry
• Candidates should have been in leadership position managing large teams.
• 18-22 years of experience, of which 10 years of leadership roles in a pharmaceutical regulated environment.
• Candidate should have prior experience with FDA 483 and Warning Letters remediation activities.

Knowledgeable in OSD Formulation Technologies.

• A strategic thinker with excellent analytical skills and results-driven, understand business needs, find the solutions and put good ideas into action.
• Good interpersonal and people management skills.
• Able to work effectively within a global business culture whilst also adaptable to the local cultural environment.
• Project Management Skills