Quality Compliance Specialist

3 weeks ago

Devens, Massachusetts, United States Veranova L P Full time
Job Description

Veranova L P is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Summary

The Quality Compliance Lead will be responsible for executing and tracking improvements in the quality compliance activities and status required within the site operations to comply with cGMP and customer expectations related to active pharmaceutical ingredient manufacturing, with a major emphasis on real-time inspection readiness and quality metrics reporting.

Key Responsibilities

  • Lead the real-time inspection readiness programs at the site through design and execution of efficient, effective internal audits and compliance monitoring programs, including conducting and overseeing auditing activities.
  • Lead GMP, and quality risk gap analyses, create and lead action plan teams.
  • Perform Quality Risk Management assessments and support other departments during risk analysis assuring the inclusion of patient safety risk and customer concerns.
  • Assist in customer complaint investigations and engagement with customer as needed for resolution.
  • Assist in creation of GMP training program to include customer and agency inspection feedback
  • Create implementation plans to address revisions in GMP regulations, ICH guidance and customer expectations.
  • Review documentation for IOQ, periodic review as well as commissioning and decommissioning of production equipment and/or laboratory instruments.
  • Manage the quality metrics monthly reporting to the global management team and create specific metrics monitoring plans to measure compliance program effectiveness.
  • Assist customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
  • Monitor audit observations, CAPA and investigations for trends, work across sites to create action plans which can be implemented across the sector.
  • Monitor the Supplier Quality Management program for service and material suppliers, including Supplier Qualification, risk assessments, performance management, and quality agreements
  • Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
  • Manage receipt and distribution of directives, regulations, and inspection reports from regulatory agencies.
  • Participate FDA inspections, audits, and inspections by other regulatory agencies.
  • Educate staff on Quality practices, including new hire quality orientation and compliance training.
  • Other duties as assigned.

Requirements

  • BS in Chemistry or equivalent
  • Minimum 5 years of experience within a Quality function for an FDA/EMA/MHRA regulated industry
  • Have previous experience auditing for cGMP compliance
  • Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
  • Experience working in global, cross-functional teams for project execution
  • Experience creating metrics for driving continuous improvement
  • Experience with drug substance or product manufacturing
  • Able to successfully interface with internal and external customers
  • Excellent analytical, written and verbal communication and presentation skills
  • Strong technical writing skills and the ability to clearly express ideas in English
  • Ability to work independently and in a team environment
  • Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum
  • Expertise in FDA regulations, EU GMP, ICH Q7 and Part 11 compliance

Preferred Qualifications

  • Experience in an Active Pharmaceutical Ingredient manufacturing environment
  • Experience in applying and implementing GMP concepts in association with bringing a product through validation to commercialization

Equal Employment Opportunity

Veranova L P is an Equal Opportunity Employer. It is the policy of Veranova L P to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

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