Nesher Pharmaceuticals (USA) LLC

Vice President and General Manager Pharmaceutical Manufacturing Jobs at Nesher Pharmaceuticals (USA) LLC

Vice President and General Manager Pharmaceutical Manufacturing Jobs at Nesher Pharmaceuticals (USA) LLC

Sample Vice President and General Manager Pharmaceutical Manufacturing Job Description

Vice President and General Manager - Pharmaceutical Manufacturing

SUMMARY

Lead the manufacturing operations to meet markets' current and future business needs by remaining compliant to a complex and ever dynamic regulatory environment to supply products of right quality, in a timely and cost-efficient manner

ESSENTIAL DUTIES AND REPSONSIBILITES

Manufacturing Leadership: Contribute in formulation manufacturing strategies, and enable the achievement of manufacturing objectives. Identify opportunities and challenges those which are appropriate to the attention of Manufacturing Organization; and facilitates discussion and deliberation. Hold self and peers accountable towards agreed objectives and support each other where necessary. Provide technical and administrative support to manufacturing sites responsible for manufacturing and packing of products.

Compliance and Quality: Promote culture of compliance as the foremost objective across manufacturing sites and employees including adherence to Quality Management Systems and Standard Operating Procedures (SOPs) at all times. Remain updated and understand the future direction of all regulatory agencies through participation in global forums (e.g. AAM), and proactively shape compliance strategies and plans. Ensure that SOPs are adequate to represent the cGMP requirements including incorporation of all the latest regulatory and quality guidelines, by working closely with CQA/IRA. Review all critical investigations, overdue CAPA closure, implementation status of regulatory commitments, implementation status of all CQA policies and all time readiness of sites.

Delivery of Goods: Work with GDSO to prepare commits for the month and plan for next 5 months production plan based on next 5 months forecast. Ensure maximum deliveries against the commits made to GDSO. Follow up with all the CFT members time to time to minimize the gap between C Vs A. Ensure all manufacturing sites meet short range demands as per the requirements generated by GDSO. Guide the team to ensure revenue targets across all markets are met On Time, In Full. Work with GDSO, PTC and CQA/IRA to ensure delivery of goods.

Technical Problem Solving: Ensure that all complex technical problems/ failures related to process and products are resolved at the earliest, keeping compliance, quality standards and long term sustainability in mind

Work closely with Tech Ops, QA, PTC, GDSO, Markets to ensure collaborative efforts through the entire process of resolution. Mitigate business risks through alternative solutions so that revenue loss is minimized while a technical issue is being resolved. Analyze trends and patterns in Out of Specs and Out of Trends, and ensure learning is cascaded across manufacturing and quality departments.

Productivity, throughput & Capacity Planning: Ensure optimum throughput and productivity from manufacturing and QC. Ensure maximum capacity utilization and minimum breakdowns through planned preventive maintenance and skill development. Ensure that plant capacities are maintained (via design) and evaluated to meet demand fluctuations, PTC exhibit batches' requirements, and all other current and future needs.  Plan capacities and/or technology through organic and/or inorganic routes. Ensure that there is a constant evaluation of Capacity vs. Demand.

Technology Innovation: Identify latest technology trends, by assimilating opinion of vendors/ partners, in equipment, processes and utilities to ensure that remains current and future-ready on cost/quality/productivity. Further, create necessary business cases for investments and convince investors. Ensure smooth technology transfer with least disruption while enabling skill development. Lead automation initiatives across all sites, and lead complex projects like eBMR. Collaborate with PTC, GDSO, QA to align on the way forward.

Operational Excellence: Drive and support Operational and Cost Excellence Programs across manufacturing operations to generate/nurture ideas and deliver measurable business impact while aligning to revenue budgets, manpower productivity. Drive and support Manufacturing Excellence initiatives across the manufacturing operations to ensure that continuous improvement projects, on areas like Packing, Granulation, Compression, etc., are being undertaken on an ongoing basis.

New Product Launches: Collaborate with GDSO, Markets, Tech Ops, QA, QC, PTC, CQA & IRA to ensure smooth launch of new products. Support PTC for manufacturing of exhibit batches on time by providing adequate resources whenever required. Devise strategies to make new products cost competitive through value engineering. Devise plans and strategies to enable manufacturing sites to respond to huge demand variations to which the new products are prone. Prepare for complex products by resourcing special equipment, and anticipating technical & regulatory challenges. Further, ensure appropriate skill-sets are developed to launch new products while ensuring that the products reach the market on time. Ensure process robustness of new products before launching.

Projects Management: Approve conceptualization, planning, costing and execution of projects related to capacity de-bottlenecking, capacity creation, automation, compliance, facility improvements etc. Conduct periodic reviews to ensure that the projects meet benchmarks on Cost, Timeline, Quality, Design and Technology and other aspects, as relevant

Facility Life-Cycle Management: Ensure life-cycle management of the manufacturing facilities including optimization and upgrade of technology and equipment. Review the manufacturing guidelines on practices, equipment and technology.

EHS: Ensure compliance of EHS standards as agreed upon. Create a culture encouraging well-being of employees and environment. Review EHS index, and ensure that Corrective and Preventive Actions (CAPA) are put in place, and are tracked through logical conclusion to prevent recurrence of the same problem

Manufacturing HR: Define appropriate structures, accountabilities and KPIs for the various manufacturing teams, and lay down the SLAs for HR. Ensure all functions/ departments are suitably manned, optimally run with right number of resources. Review findings from productivity studies and drive implementation. Drive various HR initiatives within manufacturing operations on employee engagement, skill development and improvement of work culture.

Team Development and People Management: Drive organization and culture building initiatives across manufacturing operations and support cascade of values/ desired behaviors for manufacturing. Review performance management, reward and recognition and career planning decisions for manufacturing. Support and guide focused training, knowledge management initiatives and exposure to best practices.  Facilitate recruitment of the right talent and develop them through structured coaching initiatives.  Coach, train and develop team members to enhance their skill levels to take independent decisions.  Succession planning for all critical positions. Build, maintain, and broaden a network of contacts to contribute to a positive external reputation and smooth business transactions.  Any other functions/tasks assigned by the Management, in the interest of the organization

KNOWLEDGE/SKILLS/ABILITIES

  • Complex Problem Solving
  • Technical Acumen to manage multiple dosage forms
  • Projects Management
  • Financial understanding to manage a large P&L
  • Quality and Regulatory Landscape
  • Engineering knowledge
  • US FDA, DEA and other regulatory agencies

EDUCATIONAL/EXPERIENCE

Undergraduate/ Post Graduate in Science/ Pharmacy

Minimum 25 years of total experience in Pharmaceutical Manufacturing of Solid Oral Dosage Form of which at least 10 years at leadership level

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