Develop and execute operating plans that lead to the achievement of the site and product goals.. To ensure manufacturing activities carried out in accordance with applicable GMP and GxP guidelines.. Provide direction and leadership for all site operations including but not limited to; Manufacturing, Quality Operations, Materials Management, Technical Services, Engineering, ETP as well as support functions.. Communicate effectively with various stakeholders, including but not limited to other areas within the companys supply network, external suppliers, local community, and statutory bodies.. Develop and maintain effective relationships with internal and external customers, regulators, and other stakeholders.. Develop and maintain an effective organization through effective selection, training, leadership, and management.. Support and foster operational excellence across all functions including continuous improvement.. Ensure ethics and integrity through compliance / risk management.. Create and maintain an environment that encourages teamwork, empowerment and commitment at the site.. Lead and support all kinds of regulatory audits relating to the plant.. Job Requirements. B Pharm/ M Pharm. At least 17 years experience in pharmaceutical manufacturingincluding at least 2 3 yearsexperience leading a manufacturing unit/block catering to regulated markets.. Should have experience in Semi Solids and OSD formulations, approval from EU and FDA will be an added advantage.. Has played a leadership and regulator facing role at least twice in any of the following audits USFDA, TGA, UK MHRA, EU, PICS, MCA etc.. Up to date knowledge of current GMP related GxP regulations.. Demonstrated analytical proficiency.. Experience in the latest plant related systems is a plus SAP, LIMs, SCADA, etc.. Should be currently in the BBN, Punjab, Uttarakhand or Daman area (candidates from other locations with relevant experience who are willing to relocate may be considered).. Should have been part of a greenfield / brownfield project in a lead role.. Should have an exposure to Track and Trace Requirements as per Export, EU, US and other Regulatory Requirements.