Holds Global Quality Compliance / GxP Responsibility to provide Corporate Compliance oversight of sites & managing / harmonizing processes thru Global Policy & Standards and trend and tracking data. Provides strong leadership and oversight to ensure responsibilities in regards to global actions for Quality units at sites are tracked and completed on time. In addition manages Global Recall Committee (GRC), assures on time FAR submissions to the FDA, Trends/ tracks data and Metrics. Coordinates all Global Complaints for continues improvements The candidate is accountable for assuring the harmonization of Global policies, CAPAs, Track & Trends of compliance activities such as Metrics, Recalls, Complaints , etc. leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals. Candidate will maintain oversight and supports Compliance at all sites, including harmonization and implementation of Quality Systems & procedures in alignment with Global Policies & Standards. Acts as a champion for building a “Culture of Quality” across the organization. Supports all sites for inspection readiness for all Regulatory and Customer inspections at all time.
· Ensure All Finished products and APIs intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, Sun policies & SOPS.
· Track, trend, maintain and report all global Quality and business metrics to monitor and action all QA & QC compliance activities.
· Supports site’s Quality functions to avoid non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Non-compliance issues are to be addressed via corrective and preventive actions (CAPA).
· Support sites for Regulatory inspection by proactive compliance oversight.
· Ensures rationalization and management of Quality processes, operations and systems. Performs gap analysis to plan actions for continuous improvements & Simplifications.
· Support cluster heads for Resource planning and monitoring for head count projections, revenue, budget, capital budget and manages organizational development.
· Coach and develop direct and indirect reports, as appropriate, through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities.
· Performs all work in support of our Corporate Values of Humility, Passion, Integrity, Innovation, Quality, Reliability, Consistency and Trust and in accordance with established regulatory and compliance and safety requirements.
· Lead Global Projects as part of Collaboration with GQLT. Act as key resource and provide guidance with regards to global regulations to Sun Pharma sites and affiliates to ensure overall harmonized approach to quality and compliance.
· Be a solution oriented leader and role model SUN behaviors.
· Maintain a network of subject matter experts in critical GMP Operations.
· Support the development of global strategy to respond to system level audit observations, inspection findings and implement corrective actions, globally.
· Responsible for tracking and trending of monthly global QA reports, Global KPIs, QPIs and global quality complaints and assures all compliance elements are in place.
· Responsible for all global CAPA, projects tracking and monitoring for abnormalities.
· Monitor / Support the Product Quality Center of Excellence and coordinate all 21st century activities for SUN sites.
· Trend / track the overall surveillance of commercial product after release and distribution to the market. This includes, coordinating recalls, stability failures, and associated investigations.
· Escalate to senior management, Regulatory Agency notifications of potential distributed product defects and recall recommendations.
· Monitors the regulatory and compliance landscape to understand industry trends and develop in-house regulatory/compliance strategies.
· Supports and assures timely delivery of all Health Authority Communications (reports, responses and global commitments) across all sites.
· Communicate FDA Recalls, monitor, and close and track all commitments to the Recall.
· Responsible for Global trending of Complaints.
· Ensures all FARS are submitted timely.
· Manage and lead administrative provisions, GMP work stream, global Quality payments, and third party consultants Project. Assures administrative provisions are fulfilled timely to avoid financial penalties.
· Work with legal & RA to resolve any regulatory challenges.
· Responsible for submitting quarterly USFDA updates, as required.
· Will work with all functions/ sites to improve processes based on global trending data and monthly KPIs.
· Monitor global Regulatory inspections at other companies to utilize learnings and proactive trainings.
· Will perform other work-related duties, as required.
· Master’s Degree in Chemistry, Pharmacy or relevant life scientific field is required
· Ph.D. in a related discipline would be an asset
Industrial Experience & Knowledge:
· A minimum 20 + years of experience in a pharmaceutical quality management leadership role, inclusive of directing and controlling multi-site operations and activities across multiple geographic region with good exposure of Quality and manufacturing operations is required.
· A strong knowledge of GMP’s in both domestic and international regulatory environments is required.
· Excellent and detailed knowledge of Quality/Compliance processes and programs for development and commercial products including regulatory requirements on a global level; working knowledge of safety and environment regulations and guidelines are also required.
· A proven ability to lead, manage and motivate people with a variety of skill sets is required.
· Strong organizational, interpersonal and communication skills are essential.
· Excellent negotiation skills, being able to influence others without direct reporting relation and ability to communicate effectively with all levels of the organization and external stakeholders & Health authorities including FDA.
· Ability to work effectively in an international multicultural matrix organization is strongly preferred.