ApTask
Sr Compliance and Regulatory Specialist
ApTask, Somerset, New Jersey, us, 08875
About Client:
As the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world, Company conduct all its business responsibly and with integrity. Our customers, investors and suppliers count on it, and our company's continued success depends on it.
With broad, deep-scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, company is a preferred Contract Development and Manufacturing Organization (CDMO) partner for personalized medicines, blockbuster drugs and consumer health brand extensions.
Rate Range: $120-$121.60/Hr
Job Description:
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. Roles and Responsibilities:
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 cGMP's, 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. Education & Experience:
A bachelor's 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
Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
About ApTask: ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer: At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com
Rate Range: $120-$121.60/Hr
Job Description:
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. Roles and Responsibilities:
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 cGMP's, 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. Education & Experience:
A bachelor's 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
Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
About ApTask: ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer: At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com