Site Quality Head

Description

• Ensure all finished products intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, Sun policies & Global procedures and site SOPs.
• Set site quality goals, objectives and strategic direction in alignment with Quality goals, including maintaining Site Quality Index Score.
• Track, trend, maintain and report all Quality and business metrics to monitor and action all QA & QC compliance activities.
• Prevent Quality or regulatory 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).
• Ensure rationalization and management of Quality processes, operations and systems. Perform gap analysis to plan actions for continuous improvements.
• Resource planning and monitoring for head count projections, manage site budget, capital budget and manages organizational development.
• Responsible for site lean design and execution of continuous Quality & Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance, drive efficiencies and reduce cost of poor quality.
• 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.
• Ensure the raw material, packaging material and finished products are tested and released in accordance to approved specification and test methods in a timely manner as per the site commits and support business needs.
• Ensure the DEA requirements at the site are met for controlled substances drugs.
• Lead site projects as part of Collaboration with North America Cluster Quality. 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.
• Support the development of global strategy to respond to system level audit observations, inspection findings and implement corrective actions, globally.
• Create and maintain 24/7 Inspection readiness at sites.
• Collaborate with other Heads of Quality, Manufacturing Operations, Supply Chain, Business Development, R&D, IT and Regulatory Affairs.
• Ensure the quality policies, standards and procedures for computerized systems are implemented and adhered at site.
• Ensure all GxP computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.
• Be a solution oriented leader and role model SUN behaviors.
• Maintain a network of subject matter experts in critical GMP Operations.
• This is a supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.
• Other duties as required/assigned.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy or relevant engineering or life science field is required. Candidates with advanced degree are highly preferred.
• This position requires a minimum of fifteen (15) years of experience in a pharmaceutical quality management, and minimum five (five) years of experience in leadership role.
• Significant experience in oral solid dosage 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.
• Strong comprehensive knowledge of USFDA 21 CFR regulations Part 11: EC/ER requirements, GMP requirements of various regulatory bodies – USFDA/ MHRA/ EU GMP/ PMDA.
• Strong comprehensive knowledge of ICH Guidelines, FDA and Health Canada Regulations.
• Strong comprehensive knowledge of DEA regulations and requirments.
• A proven ability to lead, manage and motivate people with a variety of skill sets is required.
• Strong organizational, interpersonal and communication skills are required.
• Excellent negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders.
• Ability to work effectively in an international matrixed organization is strongly preferred.