Quality Assurance Manager

Job Description

Job Description

Job Title: Quality Assurance Manager
Job Description

We are seeking a Quality Assurance Manager with expertise in QA Lifecycle management to join our team. The successful candidate will partner with Regulatory, Manufacturing, QA, and QC liaisons to build dossier components and ensure compliance with company SOPs and health authority regulations. This role involves managing a team of QA specialists and overseeing various quality management and audit activities.

Responsibilities

• Partner with Regulatory, Manufacturing, QA, and QC liaisons to build dossier components.
• Work within the document change system and track progress of documentation.
• Interact with responsible parties to ensure timely tracking and distribution of documents.
• Independently complete daily activities in compliance with company SOPs and regulations.
• Review documents to ensure data consistency and compliance with required formats.
• Perform audits for the Quality Management System, including investigations, documentation, training, QC and MFG data, and vendor management.
• Maintain the Training system and documentation.
• Provide monthly metrics to Quality Management.
• Ensure quality systems comply with regulatory requirements and meet AIM needs.
• Collaborate with stakeholders to keep systems updated with regulatory trends and industry standards.
• Manage a team of direct reports, overseeing their training, performance, and career development.
• Lead and coordinate on-site audits by regulatory authorities, ensuring audit readiness and follow-ups.
• Manage internal audit and supplier management programs.
• Oversee the document management system according to internal procedures.
• Review, assess, and approve change controls, non-conformances, and CAPAs.
• Ensure product quality meets company and cGMP standards.
• Perform gap analysis and propose plans to improve QMS performance.
• Identify improvement opportunities for the QMS through quality metrics evaluation.
• Oversee document storage according to company needs.
• Meet regularly with the Director to update ongoing activities and address issues.
• Ensure compliance with Health, Safety, and Environment protection rules.

• Bachelor's or Master's degree in Sciences.
• Experience in the pharmaceutical industry, preferably with small to mid-sized companies.
• Expertise in QA Lifecycle management.
• Managerial experience overseeing 2-3 direct reports.
• Proficiency in technical writing, data review, quality control, internal audit, and documentation review.
• Knowledge of GMP and pharmaceutical standards.

• Excellent written and verbal communication skills.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships.
• Availability to travel and manage travel schedules.
• Valid driver's license and proficient driving skills.
• Ability to lift up to 50 pounds.
• Awareness of research regulatory requirements, GDP, and ICH guidelines.
• Proficiency with Microsoft Office Suite.
• Knowledge of medical terminology.

Candidates will work in a fast-paced manufacturing environment with a team-oriented culture. The position is onsite five days a week with standard hours from 8:30 AM to 5:00 PM. Flexibility for overtime is required, with occasional work outside standard hours. The dress code is business casual. Candidates should be comfortable handling physical files and lifting up to 20 pounds.

Job Type & Location

This is a Contract to Hire position based out of New Brunswick, NJ.

The pay range for this position is $61.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in New Brunswick,NJ.

This position is anticipated to close on Jul 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.