Compliance and Regulatory Specialist

Compliance and Regulatory Specialist BCForward is hiring for highly motivated Senior Regulatory and Compliance Specialist in Somerset, NJ Title: Senior Regulatory and Compliance Specialist Location: Somerset, NJ Duration: 3 Months The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical application skills. This individual must be a self-starter, results oriented with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and QMS. This role is part of the Clinical Development and Supply division which is part of the broader Pharmaceutical and Consumer Health Segment within the Catalent Pharma Solutions LLC business structure. This role is based out of the Somerset, NJ site. SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: * Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required. * Facilitate and host customer audits at the Catalent Somerset site to ensure compliance with cGMPs, as well as Corporate and site standard operating procedures. * Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations. * Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities. Participate in all aspects of inspections from initiation, preparation, execution through closure. * Lead the internal audit program at the site. * Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed. * Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met. * Initiate deviations when site procedures are not followed. * Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness. * Participates in the preparation of Supplier and Customer Quality Agreements. * Participate in global supplier and regulatory meetings and effectively represent the site. * Review and approve TrackWise Records as needed acting as a QA Representative. * Review and revise departmental SOPs as required. * Comply with Environmental, Health & Safety requirements. * Other ad hoc duties as assigned. POSITION REQUIREMENTS: Education & Experience: * A bachelors degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function * Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function Knowledge: * Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required. * Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required. * Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred * TrackWise experience is preferred. * ASQ CQA or relevant Certification is highly preferred Benefits: BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k. About BCforward: Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally. BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work. BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process. This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration. Interested candidates please send resume in Word format Please reference job code when responding to this ad.

Created: 2024-10-29