Overview
On Site
Full Time
Skills
Mergers and Acquisitions
Dynamics
Quality Assurance
Quality Control
Quality Management
Corrective And Preventive Action
Change Control
Regulatory Compliance
Inspection
Auditing
Collaboration
Regulatory Affairs
Project Management
Technology Transfer
Continuous Improvement
Operational Efficiency
Training
Performance Management
Strategic Planning
Leadership
Chemistry
Pharmacy
Chemical Engineering
Pharmaceutics
API
Manufacturing
Management
GMP
Communication
Problem Solving
Conflict Resolution
Decision-making
Life Insurance
Screening
Writing
Career Counseling
Recruiting
Law
Testing
Job Details
Senior QA Manager - Permanent - Boston, MA - $1,25,000 - $1,50,000.
The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Visa sponsorship not available.
Our client is seeking a Senior QA Manager in Boston, MA.
Role Description
The Quality Manager will lead and oversee the Quality function at the site, ensuring compliance with GMP regulations, global quality standards, and customer expectations. This role will manage a team of Quality professionals and work closely with cross-functional departments to support the delivery of high-quality clinical and commercial batches. The ideal candidate brings strong leadership skills, a solid understanding of CDMO business dynamics, and hands-on experience with clinical GMP manufacturing environments.
Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
Support regulatory inspections and client audits; ensure timely and effective closure of observations.
Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
Manage and develop the Quality team through effective leadership, training, and performance management.
Contribute to the site's strategic planning as part of the site leadership team.
Skills & Requirements
Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.
Proven experience in a CDMO environment, working with multiple customers and projects.
Strong experience with clinical GMP batch manufacturing and release.
Previous experience managing and developing teams.
In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
Excellent communication skills and ability to interact effectively with internal and external stakeholders.
Strong problem-solving and decision-making skills.
Benefits/Other Compensation:
Medical, Dental, Life Insurance, 401K.
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text .
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
Applicants must be legally authorized to work in the United States. Visa sponsorship not available.
Our client is seeking a Senior QA Manager in Boston, MA.
Role Description
The Quality Manager will lead and oversee the Quality function at the site, ensuring compliance with GMP regulations, global quality standards, and customer expectations. This role will manage a team of Quality professionals and work closely with cross-functional departments to support the delivery of high-quality clinical and commercial batches. The ideal candidate brings strong leadership skills, a solid understanding of CDMO business dynamics, and hands-on experience with clinical GMP manufacturing environments.
Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
Support regulatory inspections and client audits; ensure timely and effective closure of observations.
Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
Manage and develop the Quality team through effective leadership, training, and performance management.
Contribute to the site's strategic planning as part of the site leadership team.
Skills & Requirements
Bachelor's or Master's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.
Proven experience in a CDMO environment, working with multiple customers and projects.
Strong experience with clinical GMP batch manufacturing and release.
Previous experience managing and developing teams.
In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
Excellent communication skills and ability to interact effectively with internal and external stakeholders.
Strong problem-solving and decision-making skills.
Benefits/Other Compensation:
Medical, Dental, Life Insurance, 401K.
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
Nervous about an upcoming interview? Unsure how to write a new resume?
Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.
Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text .
Drug testing may be required; please contact a recruiter for more information.
#LI-DNI
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.