The world’s largest pharmaceuticals market is also the biggest market for Sun Pharma. We have been present in the US since 1996, working with the country’s healthcare system with a focus on generics, branded generics and over-the-counter (OTC) products. We are valued suppliers to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers. Being a vertically integrated company with a global presence, we have the flexibility to develop and manufacture products in the US as well as at other locations across the world. Our US headquarters is located in Cranbury, New Jersey and we have manufacturing, distribution and customer service teams at multiple locations across the country.
For the Global R&D Quality Assurance Department, this position leads and directs one of Global R&D Quality teams responsible for designing, implementing, and monitoring the CMC Quality System supporting the development of NCE, Drug Substance, and Drug Products.
Essential Job Functions:
Supporting the development, validation and transfer of robust formulations, manufacturing processes and analytical methods.
Designing, implementing and enabling processes/practices such as R&D stage gate deliverables, development standards, acceptance criteria, etc. within various areas of R&D i.e. CRD/PDR/AD/RA.
Building talent, skills, and competencies needed within R&D Quality to support Developmental R&D and ensuring that the group delivers value and gain acceptance with R&D while capabilities are being built.
The Associate Director/Director of R&D QA:
Partners with R&D to assure formulations, manufacturing processes, and analytical methods are adequate and justified prior to transfer to manufacturing sites.
Assures the completeness and accuracy of Product Development Reports and Technology Transfer Dossiers.
Sustains substantial compliance of quality operations at R&D sites and subcontract R&D facilities.
Works with R&D to jointly design, implement, and sustain enabling processes, such as R&D stage gate deliverables/acceptance criteria and development standards.
Supports identification, due diligence and approval of new, third-party R&D partners in conjunction with Regional Quality.
Provides support to Corporate Quality Audit team during audits of R&D facilities.
Ability to travel domestically and internationally as needed.
Execution of QA program as per GxP principles and overview of the same.
Monitoring of in-vitro study raw data and report review.
Monitoring of overall document management system and raw data recording system.
SOP, ATP, Study protocol, quality system documents approval.
Training and assessment of training for new joinee.
Imparting training/monitoring training program.
Approval of event/incident investigation, deviation, OOS and change control system.
Ensure that R&D remains always one step ahead of new regulatory trends.
Perform other duties as assigned.
Understanding regulations and requirements of different countries and decision making without compromise on Quality.
Understanding the intricacies of product and process development.
Coordination with highly technical oriented team of R&D Leaders and Scientists.
Goals: Set R&D Quality Team goals, objectives, and strategic direction in alignment with Global Quality & Compliance and R&D goals
Strategy: Collaborate with R&D Stakeholders (i.e. ARD, PDR and CRD heads) to shape functional strategy and align with overall Quality and R&D strategy.
Mentorship: Teach Team members within R&D Quality critical quality management skills, including decision-making, handling of quality exceptions, staff development, personnel and budget requirements planning, etc.
Daily Operations: Provide leadership and direction to ensure achievement of all functional accountabilities and Responsibilities for R&D Support within CQA.
Management Review: Execute product quality reviews within R&D; monitor product development and set improvement areas.
Resource Adequacy and Development: Determine the departmental staffing plan annually or periodically in view of R&D work. Plan and manage organizational development, including interviews and selection, mentoring, coaching, counselling, performance management and compensation.
Minimum of Masters in Chemistry or Pharmaceutical Sciences
Minimum 10+ years of pharmaceutical industry experience, preferably in both Pharmaceutical Development & Quality
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office or manufacturing environment. The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.
Must be capable of bending and lifting, moving and/or carrying approximately 50 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.