Sr. Manager, QA Compliance

HeaderJob DescriptionThe Manager QA, Compliance (QMS) is responsible for establishing and implementing a robust compliance program, which includes analytical investigations and laboratory management in compliance with FDA regulations, guidance, and other recognized industry standards. The position is also responsible for digitization of quality management and laboratory information systems compliance with Corporate and Site procedures and escalating issues to site leadership for remediation. Planning and implementation of robust procedures for analytical development related investigations and strengthen root cause analysis Propose, review, and/or implement appropriate corrective actions and preventive actions (CAPA) based on the observations. Evaluation of change controls for developmental and commercial products, Liaise with SMEs to identify additional procedural controls for overall improvement of compliance. Perform Risk Analysis for the products/materials in collaboration with SMEs. Escalate risks/issues to site leadership where necessary Verify the CAPA effectiveness periodically and modify the CAPA accordingly. Method development, validation, transfers and analysis of APIs, Excipients necessary for tech transfers of liquids, gels, tablets and drug device combinations and Preservatives in Liquid formulations as per USP and ICH guidelines Qualification and ExperienceMinimum bachelor's degree in a scientific or technical field; graduate degree desired 5+ years of extensive experience in the pharmaceutical industry in Quality Assurance. Cross-functional experience in Manufacturing, Packaging, Engineering, Technical Operations, Laboratory or Product development is a plus Working knowledge of FDA and applicable non-US regulations, guidance and industry standards about pharmaceutical drug manufacturing and auditing Experience with internal/external auditing and hosting customer / regulatory audits is required. ASQ-CQA certification desired Excellent verbal and written communication skills Experience in using electronic Quality Management System, ERP system, MS Office applications, Veeva experience desirable Other responsibilities in quality systems as deemed necessary by the management Work Schedule The regularly scheduled workweek is Monday through Friday, and the hours are generally 8:00 am - 5:00 pm or 9:00 am - 6:00 pm. Domestic / International Travel of up to 25% The anticipated salary range for this position in New Jersey is $100,000.00 - $150,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states. Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran's status, or any other classification as required by applicable law. Physical Requirements The physical requirements of the position generally include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in an office environment. Search Firm Representatives Please Read Carefully Lupin USA, and its Affiliates, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails. CompetenciesCollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility