Apozealpharma
Director Of Quality, Regulatory, Pharmacovigilance
Apozealpharma, Levittown, Pennsylvania, United States, 19055
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:
LevittownThe 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. sitePerforms GAP analyses, risk assessments, and proactively implements quality policies and procedures in accordance with CGMP, and other regulatory requirementsResponsible 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 commitmentsResponsible for conducting training and managing training program.Manages quality contract and agreements with vendors, suppliers, and clientsManages customer complaints program. Reviews and approves complaint investigation reports and corrective actions.Manages investigation, commitment tracking, audits and training database. Review and approve commitmentsProvides 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 assessmentsPrepares 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 bodiesReviews 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 AffairsPrepares budget for the departmentManages within the allocated budget and resourcesPrepares monthly departmental performance reportActs as a liaison between all cross functional departments to resolve compliance issuesQualifications:Excellent understanding of CGMPs, other regulatory guidance, company procedures and policies.Should have experience in problem solving and timely resolutionsBS/MS degree in chemistry, biology, pharmacy or related scientific disciplineMinimum 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 auditsExperience interacting directly with the regulatory agenciesExperience handling complaints, review of non-conformance investigations, qualification protocols etc.Excellent People, Communication and Technical Writing SkillsKnowledge of computer programs such as Excel, Access, Power Point, Statistical software is requiredApply for Job
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LevittownThe 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. sitePerforms GAP analyses, risk assessments, and proactively implements quality policies and procedures in accordance with CGMP, and other regulatory requirementsResponsible 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 commitmentsResponsible for conducting training and managing training program.Manages quality contract and agreements with vendors, suppliers, and clientsManages customer complaints program. Reviews and approves complaint investigation reports and corrective actions.Manages investigation, commitment tracking, audits and training database. Review and approve commitmentsProvides 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 assessmentsPrepares 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 bodiesReviews 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 AffairsPrepares budget for the departmentManages within the allocated budget and resourcesPrepares monthly departmental performance reportActs as a liaison between all cross functional departments to resolve compliance issuesQualifications:Excellent understanding of CGMPs, other regulatory guidance, company procedures and policies.Should have experience in problem solving and timely resolutionsBS/MS degree in chemistry, biology, pharmacy or related scientific disciplineMinimum 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 auditsExperience interacting directly with the regulatory agenciesExperience handling complaints, review of non-conformance investigations, qualification protocols etc.Excellent People, Communication and Technical Writing SkillsKnowledge of computer programs such as Excel, Access, Power Point, Statistical software is requiredApply for Job
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