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Quality Assurance Manager

3 months ago

Brockton, Massachusetts, United States Clinical Dynamix Full time

Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding

Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.

Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Practices (GDP) activities.

In addition, this role will perform critical quality assurance activities such as Change Management, SOP Management, and Audit oversight.

Position requires on-site presence at companies HQ

Essential Duties and Responsibilities

  • Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
  • Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. This includes documentation control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems.
  • Reviewing and Approving Documentation: Manage the document lifecycle of Standard Operating Procedures (SOPs) and contribute to procedural changes as needed to meet GMP, corporate and regulatory requirements. Create, route and track controlled records within documents management system, Veeva. Reviewing and approving documents such as Standard Operating Procedures (SOPs), batch records, protocols, and reports to ensure accuracy, completeness, and compliance with regulatory requirements.
  • Performing Audits and Inspections: Conducting audits and regulatory inspections to assess compliance with GMP and GDP requirements. Sets and manages audit schedule collaborating with Tech Ops and internal QA to ensure audit reporting reflects current state of compliance at COs and to help address issues requiring remediation. Identifying non-conformances, implementing corrective actions, and ensuring follow-up to address audit findings.
  • Managing Supplier and Vendor Quality: Assessing and approving suppliers and vendors based on their adherence to GMP and GDP standards. This involves conducting supplier audits, evaluating supplier documentation (including quality agreements), and ensuring the quality of incoming materials and products.
  • Investigating Quality Issues: Investigating quality issues, deviations, complaints, and out-of-specification results to determine root causes and implement corrective and preventive actions to prevent recurrence.
  • Quality Risk Management: Implementing quality risk management processes to identify, assess, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle.
  • Supporting Validation Activities: Providing quality oversight and support for validation activities, including process validation, equipment qualification, analytical method validation, and cleaning validation, to ensure compliance with regulatory requirements.
  • Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
  • Reporting and Tracking: Providing internal customers with status reports, inspection results, improvement updates and other KPI and regulatory/quality required reporting. Provide updates to North American leadership team of progress. Manage offsite storage for all documents for the Bridgewater office, including detailed inventory and data entry into IM Connect for tracking purposes.

Education and Experience

  • Bachelors degree in related field, or equivalent experience required.
  • Minimum of 7 years experience in a GxP role; Pharmaceutical experience is preferred. Experience collaborating with CMOs to obtain deliverables is recommended.
  • Experience with Veeva (Quality Docs, QMS and Training modules) a plus.
  • Solid understanding of GMP regulations, CFR 21 Parts 210, 211 and 600 + GDP regulations USP NF1079 / USAP NF 1083
  • Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance principles.
  • Ability to interface with internal and external customers at all levels.
  • Ability to process information quickly and correctly while maintaining a high level of customer service and communication.

Intermediate knowledge of Microsoft Word, Microsoft Excel and Adobe Acrobat

Knowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommended

Excellent communication, organizational, interpersonal and computer skills

Excellent Oral/Written Communication Skills

Demonstrated ability to manage multiple competing priorities

Solid organizational skills and attention to detail