Manager I, Quality Assurance

At Avantor, people are the most important part of our success because they drive our global performance. That’s why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor’s Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

The Quality Assurance Manager is responsible for establishing and maintaining procedures and techniques for Quality Assurance Activities. Assist in the coordination of manufacturing and engineering and confers with customers to define and resolve product quality issues. Interact with Leadership to advise necessary continuous improvement efforts so that systems and processes are in line with overall company strategy and quality policy. Provide technical input and implement process and documentation changes. Manages a large team of experienced professionals with a focus on policy and strategy implementation, as well as implementing short-term operational plans.

This position reports into the Director, Quality Assurance and will report into our Devens, MA location.

What we’re looking for:

• Education: Bachelor’s Degree in a related scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology)
• Experience: 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).

Who you are:

• 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 KPI’s 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. Regularly share information, provide context, and ensure clarity in expectations and goals.
• Empower your team members by delegating responsibilities and granting them autonomy to make decisions within their roles. Trust their expertise, provide necessary resources and support, and encourage them to take calculated risks. This fosters a sense of ownership, confidence, and accountability among team members.
• 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. Recognize their contributions publicly, both within the team and to the larger organization. Reward their performance through incentives, promotions, or other forms of recognition, which reinforces a positive and motivated work environment.
• Foster collaboration among team members, promoting an inclusive and supportive team culture. Encourage diverse perspectives, facilitate constructive discussions, and emphasize the value of teamwork.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.