Job Description

APOZEAL is a pharmaceutical company that is focused on the development and manufacturing of high-quality branded and generic pharmaceuticals across a broad range of therapeutic areas. Location: Levittown The Director of Quality, Regulatory, Pharmacovigilance oversees and manages activities responsible for all quality related activities including but not limited to internal and external audits, complaints-handling, annual product reviews, commitment-tracking, non-conformance investigations, vendor qualification and certification, training program, DEA, recall management, regulatory, pharmacovigilance and supports all compliance related activities. Major Tasks, Key Responsibilities and Key Accountabilities: Lead and direct all quality related activities including but not limited to the purview of Quality Control, Quality Assurance, Document Control, regulatory, pharmacovigilance and Compliance. Enforces and elevates quality and compliance standards across entire Apozeal Pharma Inc. site Performs GAP analyses, risk assessments, and proactively implements quality policies and procedures in accordance with CGMP, and other regulatory requirements Responsible for Quality, Regulatory Affairs, & Pharmacovigilance in facilitating audits conducted by regulatory agencies, customers, and clients. Write and prepare the responses to the audit findings by regulatory agencies, customers, and clients. Manages internal and external audit program, prepares yearly audit schedule. Reviews audit reports and responses for accuracy and completeness and follow-up on corrective actions and commitments Responsible for conducting training and managing training program. Manages quality contract and agreements with vendors, suppliers, and clients Manages customer complaints program. Reviews and approves complaint investigation reports and corrective actions. Manages investigation, commitment tracking, audits and training database. Review and approve commitments Provides guidance on conducting investigations and root cause analysis. Reviews and approves investigations for adequacy of root cause determination and CAPA actions. Makes decisions on disposition of Raw Materials, Finished Products, Components, Equipment impacted by the investigations. Manages Annual Product Review program. Reviews and approves Annual Product Reviews. Guides other cross functional areas and prepares risk assessments Prepares monthly reports, quality scorecards, trending charts, meeting minutes for the Quality Review Meetings. Escalates quality and Compliance issues in a timely manner. Evaluates and enhances site wide and departmental procedures and policies to ensure compliance with CGMPs , company policies, and other regulatory bodies Reviews and approves change controls, investigation, validation and qualification protocols and reports. Manages DEA reporting, cages, vaults in accordance with DEA regulations. Maintains all regulatory certifications, licenses, registrations including DEA. Head of Quality & Regulatory Affairs Prepares budget for the department Manages within the allocated budget and resources Prepares monthly departmental performance report Acts as a liaison between all cross functional departments to resolve compliance issues Qualifications: Excellent understanding of CGMPs, other regulatory guidance, company procedures and policies. Should have experience in problem solving and timely resolutions BS/MS degree in chemistry, biology, pharmacy or related scientific discipline Minimum of 15 years of pharmaceutical industry experience in QC/QA of which 5 years in a supervisory role and managing direct & indirect reports. Experience in conducting and facilitating internal and regulatory audits Experience interacting directly with the regulatory agencies Experience handling complaints, review of non-conformance investigations, qualification protocols etc. Excellent People, Communication and Technical Writing Skills Knowledge of computer programs such as Excel, Access, Power Point, Statistical software is required Apply for Job Fill out the form below and we will contact you. #J-18808-Ljbffr Apozealpharma

Job Tags

Similar Jobs