Manager of Quality Assurance Operations job in Cambridge, USA

��

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Manager of Quality Assurance Operations - Contract - Cambridge, MA

�� is seeking a Manager of Quality Assurance Operations to join a dedicated team.

Primary Responsibilities:

This role will assist with all GMP aspects of drug product manufacturing and alliance management. The successful candidate will work closely with Quality Operations to ensure that clinical and commercial lifecycle activities comply with cGMP regulatory requirements. This position involves collaboration with internal and external partners to maintain high-quality standards.

Skills & Requirements:

Degree in life sciences, engineering, or related field.
Minimum of 5 years experience in Quality Assurance within pharmaceutical or biopharmaceutical companies.
Familiarity with external Contract Manufacturing Organizations in a virtual setting.
Knowledge of aseptic techniques and parenteral drug manufacturing operations.
Experience with GMP management and exposure to regulatory authorities like FDA, EMA, PMDA, or ANVISA.
Preferred experience with investigational and commercial products in Quality Operations.
Experience working with Alliance Partners is a plus.
Ability to improve processes and turnaround times.

The Manager of Quality Assurance Operations' responsibilities will be:

Oversee quality assurance for external manufacturing of clinical and commercial drug products.
Review and approve internal and external Deviations, Change Controls, and CAPAs.
Support QA review and data verification for clinical regulatory filings.
Collaborate with alliance partners to ensure compliance with quality systems and practices.
Work with colleagues and vendors to address complex quality issues and find compliant solutions.
Report timely and accurate metrics for KPI and risk register tools.
Drive continuous improvement to mitigate risks and support business needs.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

�� is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

�� Staffing is an equal opportunity employer.

INDCQA

Salary

Highly Competitive

Location:

Augsburg, Germany

�� is seeking a Sr. Quality Management Research & Discovery Specialist to join a dynamic team in the medical devices sector.

Jana Birli

Apply

Quality Assurance Operations Specialist I

Salary

Highly Competitive

Location:

Philadelphia, USA

�� is working alongside a pharmaceutical company to recruit for a Quality Assurance Operations Specialist I. This temporary contract position is based in Philadelphia, Pennsylvania.

Anderson Maldonado

Apply

Scientist QC Raw Materials

Salary

Highly Competitive

Location:

Visp, Schweiz

�� is seeking a dedicated Scientist QC Raw Materials to join a team focused on quality control within the Primary Packaging and Raw Material sector.

Ashley Bennett

Apply

Sr QA Specialist

Salary

US$55 - US$63 per hour + Highly Competitive Salary

Location:

Cambridge, USA

�� is seeking a Quality Assurance Specialist to join our team. In this role, you will focus on maintaining quality and regulatory standards within manufacturing processes.

Anderson Maldonado

Apply

Material Planning Analyst (Senior)

Salary

Highly Competitive Salary

Location:

Solothurn, Switzerland

�� is seeking a dedicated Materials Planning Specialist to support manufacturing planning for clinical and commercial programs.

Ashley Bennett

Apply

Biomanufacturing Associate

Salary

Highly Competitive Salary

Location:

Philadelphia, USA

�� is seeking a Manufacturing Associate to join our team in Philadelphia.

Mike Raletz

Apply

QA Project Leader for Drug Product

Salary

Highly Competitive

Location:

Visp, Switzerland

�� is currently working alongside a contract manufacturing organisation to recruit for a QA Project Leader for Drug Product. This temporary contract position is based in Visp, Switzerland.