Job Description

Job Title: Quality Assurance Manager
Location: Massachusetts (Onsite)
Job Type: Full-time
Job Description

We are seeking an experienced Quality Assurance Manager to lead and manage our Quality Assurance (QA) team. The ideal candidate will ensure that all quality processes comply with regulatory standards and align with business objectives. This role involves overseeing the Quality Management System (QMS), maintaining compliance with current Good Manufacturing Practices (cGMP), and fostering continuous quality improvement.
Duties and Responsibilities

Supervise and mentor the Quality Assurance (QA) team, including responsibilities for recruitment, training, and performance coaching.

Oversee and manage the Quality Management System (QMS), ensuring adherence to regulatory standards for drug quality, strength, identity, and purity throughout production and storage.

Develop, implement, and maintain Standard Operating Procedures (SOPs) related to quality assurance activities.

Design and implement programs to enhance quality standards and ensure compliance with business and regulatory requirements.

Define and enforce inspection standards within the QA department.

Conduct and manage internal audits to verify compliance with cGMP requirements.

Develop and oversee a company-wide cGMP Training Program.

Lead the Change Control Committee, ensuring proper documentation and approval for facility, equipment, product, and process modifications.

Review and approve operational procedures related to manufacturing, production, testing, and maintenance, including associated documentation.

Ensure proper quality controls are in place and successfully executed during manufacturing operations.

Analyze and address any discrepancies found in production records.

Serve as the QA department's representative in various organizational meetings.

Develop, manage, and monitor the department's annual budget.

Oversee the hiring process and manage personnel changes within the QA department.

Direct and oversee the daily operations of the QA Department.

Qualifications and Experience

Education: B.S. in a Science-related field (Chemistry, Biology, Pharmacy) or equivalent.

Experience: Minimum of 5+ years of managerial experience in a QA environment, preferably in the generics pharmaceutical industry.

Expertise: Extensive knowledge of cGMP requirements and Quality Assurance functions.

Skills: Strong written and verbal communication skills, problem-solving abilities, and attention to confidentiality.

If you are a highly motivated QA professional with leadership experience and a strong background in cGMP compliance, we encourage you to apply.

#QualityAssurance #FDA #generics #Quality #pharmaceutical

Job Tags

Permanent employment, Full time,

Similar Jobs

Playstack

Associate Game Designer - Pacific Time Zone Job at Playstack

...Who We Are: We are Playstack the premium indie games publisher helping bold, creative developers bring their visions to life.... ...We believe that it is the people who define the culture of the Company and build its successes. We're committed to creating a workplace...

FlexCare

Healthcare Recruiter Job at FlexCare

...management solutions, connecting top clinicians with leading healthcare facilities across the U.S. Since 2006, we have been committed... ...Ready to grow with us? Apply today. **This is a phone sales recruiting role, not an HR or corporate recruiting role, and is 100% in-...

Baylor Scott & White Health

Physician Assistant - Behavioral Health Job at Baylor Scott & White Health

**Job Title: Physician Assistant - Behavioral Health (Fully Remote)****Location** : Fully Remote**Schedule** : Monday - Friday, 8:00 AM... ...up visits** with patients who have already been assessed by psychiatry, addressing their ongoing mental health needs.+ Providing...

Olympic View Christian Daycare

Early Childhood - Teacher Assistant/Aide Job at Olympic View Christian Daycare

...been operating in the NE Tacoma area since 1969. We are licensed for 75 children and employ 19 staff. We currently have a Teacher's Assistant/Aide position available to add to our team. We highly value the diverse cultural backgrounds in our team, viewing these differences...

Firetrol Protection Systems

Fire Systems Inspector Job at Firetrol Protection Systems

...Founded in 1984, Firetrol is the national leader in fire protection & life safety services. We are currently seeking a skilled Fire Systems Inspector to join our team of the best fire protection professionals in the industry. This position is based in our Tucson, AZ...

Quality Assurance Manager Job at Barrington James, Massachusetts

N005UUJBaW0yUThsWkRSdnB1UnF0cGRxUFE9PQ==