Director Of Quality, Regulatory, Pharmacovigilance

2 days ago

Levittown PA United States Apozealpharma Full time

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
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