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Director of Quality Operations

Berkshire Sterile Manufacturing Llc
Full-time
On-site
Lee, Massachusetts, United States
$90,000 - $160,000 USD yearly

Position Summary

The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignment with customer & regulatory requirements and company objectives. The role requires a blend of technical expertise, analytical thinking, and leadership skills to address challenges, optimize processes, foster a culture of continuous improvement across the organization and enhance client relationships.

Duties and Responsibilities

  • Ensure compliance with cGMP, FDA, and other applicable regulatory requirements for sterile drug manufacturing.
  • Lead the team in quality oversight of manufacturing processes, ensuring adherence to SOPs and quality standards.
  • Drive initiatives to strengthen aseptic technique, contamination control strategies, and data integrity practices.
  • Support the development and maintenance of a robust risk management program, ensuring all critical issues are addressed with sustainable solutions.
  • Serve as the quality operations representative during internal and external meetings with clients and other entities.
  • Respond to client inquiries, quality concerns, and requests in a timely and professional manner.
  • Oversee the resolution of client-related deviations, investigations, and CAPAs, ensuring timely closure.
  • Provide root cause analysis and implement preventive measures for recurring client concerns.
  • Lead cross-functional teams to ensure effective resolution of quality issues impacting clients.
  • Facilitate effective communication between clients and internal stakeholders to ensure alignment on quality objectives.
  • Travel as needed
  • Other duties as assigned

Regulatory Responsibilities  

  • Keep abreast of changes to quality regulations and guidelines, advise the management team of any business implications of these changes
  • Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
  • Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211 and other regulatory agency requirements

Supervisory Responsibilities

  • Lead and direct work and provide feedback to a team of QA Specialists 
  • Lead, manage and ensure proper training to any relevant change management  programs throughout the company

Experience

  • Eight to ten (8-10) years of progressively responsible related quality assurance experience

Education

  • Bachelor's Degree

Knowledge, Skills & Abilities

  • Subject matter expertise in FDA, EU, and other regulatory agency requirements
  • Comprehensive knowledge of QA concepts and principles
  • Knowledge of cGMP principles
  • Knowledge of RCA tools
  • Ability to work as part of a team
  • Management skills
  • Ability to manage multiple client relationships and priorities effectively
  • Good oral and written communication
  • Problem/situation analysis
  • Ability to build collaborative relationships
  • Uses good judgement
  • Perform complex work instructions and problem solving following established processes
  • Experience with Microsoft Office and general computer proficiency
  • Quality mindset and a willingness to develop yourself and others

Physical Requirements

 

  • Ability to remain stationary for long periods of time
  • Ability to move between locations
  • May occasionally lift up to 10 lbs.