Senior QA Manager

About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States. Job Title Senior QA Manager Organization Name InvaGen Pharmaceuticals Location 550 South Research Place Central Islip, NY 11722 600 Old Willets Path Hauppauge, NY 11722 Employment Type (Hourly/ Full Time) Full Time - Salaried/Exempt Salary Range (Base/ Hourly) $95,000 - $117,500 Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits Work Hours/ Shift/ Remote 8:30 AM - 5:00 PM Responsibilities/ Accountabilities Ensure employees and processes comply with current Good Manufacturing Practices and company procedures at Cipla USA OSD plants. Support of site and company-wide objectives through the reporting of department Key Performance Indicators Oversee Unit-3 site operation QA activities including both Manufacturing and Packaging. Follow standard operating procedures and execute change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Regulatory Services, Research & Development, and Supply Chain to meet site and corporate objectives. Support audit readiness and assisting with audit preparation, regulatory inspections, and customer audits. Support a quality and compliance focused culture which embraces RFT and CI expectations in partnership with the site leaders. Maintain working knowledge of government and industry quality assurance regulations and standards. Establish and maintain effective cross functional relationships. Supports regulatory inspections and customer audits for the site Manage the corporate and site programs (i.e. self-improvement audits) to assess and improve the state of compliance of cGMPs. Manage Site Master File and Quality Manual program. Support Change Control & Corrective/Preventive Action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness. Communicates shopfloor metrics (deviations, change controls, CAPA etc.) trends to leadership Provide leadership to the Quality and Compliance function, manages, and provides development support to department personnel Provide leadership and coaching to shop floor quality team members. Education Qualifications A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred. Experience working in pharmaceutical QA is preferred. Proficiently speak English as a first or second language. Proficiently communicate and understand (read and write) scientific / regulatory based 'work" in English. Have excellent organization, learning and teaching skills required to work in teams. Strong desire towards continuous improvement. Know how to use Microsoft Office programs and other scientific based software Experience Minimum ten (10) years of experience in quality operations in a pharmaceutical (cGMP/FDA regulated) industry. Minimum five (5) years of management experience. Prior experience in Oral Solid Dosage Manufacturing. Knowledge of regulatory requirements as they pertain to pharmaceutical manufacturing and related GMP as per company policies and SOPs. Physical Requirements Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required. Able to wear appropriate personal protective equipment at all times, when required. Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period. Other Information This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required. The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required. No remote work available. Relocation available. Equal Opportunity Employer Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard towithout regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected bylocal, state, or federal laws, rules, or regulations. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact . Pre-employment Process Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing. Disclaimer on Pay Ranges About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results. Cipla USA and its US Affiliates is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status. Minimum Salary: 31200.00 Maximum Salary: 31200.00 Salary Unit: Yearly

Created: 2024-10-19