Job SummaryProvide strong leadership and oversight to ensure responsibilities in regards to QA, QC and Compliance activities. The position is accountable for assuring the supply of quality products to Sun Pharma customers and markets, and ensuring cGMP compliance at the site. Responsible for leading, directing, identifying and setting quality goals, objectives, and perfect execution in alignment with Global Quality Goals. Maintain cGMP compliance at site, including harmonization and implementation of Quality Systems & procedures in alignment with Global Policies & Standards. Ensuring the materials and products are tested and released in a timely manner by adhering to approved procedures and specifications. Acts as a champion for building a "Culture of Quality" across the organization. Accountable to assure site is ready for all Regulatory and Customer inspections at all time.
Areas of Responsibility- 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.
Education and Job 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.
Physical Requirements:- While performing the duties of this job the employee frequently is required to sit, stand; talk, hear, walk; use hands and fingers to operate a computer, telephone, keyboard and mouse. Light lifting up to 20lbs. is required.
- The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
- Close (Near) and color vision
Environmental related to manufacturing/production environments:- Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
- Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
- Odors: Unpleasant smells.
- Gases: Examples include carbon monoxide and ozone.
- Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
The presently-anticipated base compensation pay range for this position is $206,000 to $229,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
