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.
• Responsible for vendor qualification management
• 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