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Quality Assurance Manager

1 month ago

Devens, Massachusetts, United States Avantor Full time
The Opportunity:

Avantor is a global leader in the life sciences industry, and we're seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our Quality Assurance & Quality Systems vertical, you will play a critical role in ensuring the quality and integrity of our products and processes.

Key Responsibilities:
  • Establish and maintain procedures and techniques for Quality Assurance Activities
  • Assist in the coordination of manufacturing and engineering, and confer with customers to define and resolve product quality issues
  • Interact with Leadership to advise on necessary continuous improvement efforts, ensuring that systems and processes are in line with overall company strategy and quality policy
  • Provide technical input and implement process and documentation changes
  • Manage a large team of experienced professionals, focusing on policy and strategy implementation, as well as short-term operational plans
Requirements:
  • Bachelor's Degree in a related scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology)
  • 5+ years of Quality assurance or quality control experience within the biopharmaceutical or related industry
  • Team management experience, preferably within the quality vertical
  • Regulatory requirements, such as GMP, GLP, and relevant guidelines (e.g., ISO, FDA, EMA guidelines)
  • Quality Management System: Establish and maintain an effective quality management system in accordance with applicable regulatory requirements, industry best practices, and company policies
  • Regulatory Compliance: Ensure compliance with relevant regulatory agencies (such as ISO, FDA, EMA) and applicable guidelines, including Good Manufacturing Practices (GMP)
  • Quality Assurance Processes: Develop and implement quality assurance processes, including batch record review, deviation management, change control, investigations, and CAPA (Corrective and Preventive Actions) systems
  • Documentation Control: Oversee the document control system, including document creation, review, approval, distribution, and archiving, to ensure accuracy, completeness, and compliance
  • Audits and Inspections: Prepare for and participate in internal and external audits and inspections, addressing findings, and implementing corrective actions as necessary
  • Supplier and Vendor Management: Collaborate with cross-functional teams to qualify and manage suppliers and vendors, conducting audits, and ensuring adherence to quality standards
  • Training and Education experience: Develop and deliver training programs to enhance quality awareness and compliance among employees, contractors, and suppliers
  • Risk Management: Identify and assess quality-related risks, develop risk mitigation strategies, and monitor the effectiveness of risk control measures
  • Quality Metrics and Reporting: Establish key quality metrics and generate reports to track performance, identify trends, and communicate quality-related information to management
  • Continuous Improvement: Drive continuous improvement initiatives, implementing Lean Six Sigma methodologies and other quality improvement tools to enhance operational efficiency and product quality
Preferred Experience:
  • Experience with biopharmaceutical manufacturing processes, including cell culture, purification, and aseptic techniques
  • Proven track record in managing quality management systems, audits, and regulatory inspections
  • Expert understanding of quality assurance principles, methodologies, and tools, including CAPA, deviation management, and change control
  • Familiarity with risk management techniques and application of quality improvement methodologies (e.g., Lean Six Sigma)
What We're Looking For:
  • Effective analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective and preventive actions
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams and communicate complex quality concepts to both technical and non-technical stakeholders
  • Attention to detail, strong organizational skills, and the ability to prioritize and manage multiple tasks in a dynamic work environment
How You Will Thrive and Create an Impact:
  • Plan, direct, and implement strategic business plans involving product and process quality by utilizing statistics and metrics, as appropriate, to evaluate trends and to aid management in the identification and resolution of quality issues and overall quality improvement efforts
  • Facilitate all aspects of a Quality System that is certified to ISO 9001 and/or ISO 13485 and that is compliant with the FDA's current Good Manufacturing Practices (cGMPs)
  • Resolve internal product and process issues through established nonconformance and CAPA systems
  • Facilitate an effective complaint handling process
  • Ensure that the QA team is conducting customer audits and handling customer requests for quality-related information
  • Be a subject matter expert for all applicable regulations (FDA, ISO, AAMI, etc.) ensuring the proper processes, policies, and procedures are in place to obtain customer part qualification approvals and to maintain regulatory compliance
  • Recommend KPIs to measure compliance with quality standards and effectiveness of corrective actions across all functions
  • Develop and lead people by cultivating their skills, empowering them to reach their full potential, and guiding them towards shared goals
  • Articulate a direction that inspires and motivates your team, helping them understand the value of their work and how it contributes to the overall quality objective(s)
  • Foster open and transparent communication channels; actively listen to your team members' concerns and ideas and provide feedback that is constructive and supportive
  • Empower your team members by delegating responsibilities and granting them autonomy to make decisions within their roles
  • Embody a culture of inclusiveness
  • Create a learning culture that encourages growth and development
  • Support your team members' professional development through training opportunities, mentoring, and coaching
  • Provide constructive feedback and help them set clear goals to enhance their skills and advance their careers
  • Acknowledge and appreciate your team members' efforts and achievements
  • Foster collaboration among team members, promoting an inclusive and supportive team culture