Quality Assurance Manager

ACE Partners; New Jersey; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) with company match

Employee stock purchase plan

Parental leave (6 weeks)

Job summary

ACE Partners, a 6B global life sciences business, seeks a hands-on QA Manager to lead quality at a major US manufacturing site. You will oversee the QA team, drive CAPA, audits, and root-cause investigations on the plant floor.

Ensure cGMP compliance, align the QMS with FDA/ISO requirements, and collaborate with customers and suppliers on corrective actions. Strong leadership in a unionised environment required on site.

Qualifications

• Bachelor's in chemistry or life science or equivalent experience.
• Experience in a chemical manufacturing plant (salts, solvents, acids, high-purity materials).
• 5+ years in quality systems within chemical, high-purity or FDA-regulated manufacturing.
• Strong working knowledge of FDA and ISO quality system requirements.
• People leadership experience, ideally in a unionised environment.

Responsibilities

• Lead and develop the site QA team.
• Own the CAPA program, internal audits and root cause investigations.
• Lead complaint investigations and keep the site cGMP compliant.
• Keep the QMS aligned with FDA and ISO requirements.
• Work with customers and suppliers on corrective actions and approvals.
• Partner with Production on product reliability and inspection.
• Spend real time on the plant floor with operators and supervisors.

Skills

QA management

CAPA program

Internal audits

Root cause investigations

FDA & ISO compliance

People leadership

Manufacturing quality

Plant floor presence

Union environment leadership

Education

Bachelor's in Chemistry or Life Science

Job description

A $6B global life sciences business is looking for a hands-on QA Manager to lead quality at one of its key US manufacturing sites. It's a 40+ building campus producing high-purity salts, solvents and acids for biopharma and research customers.

What you'll do

• Lead and develop the site QA team
• Own the CAPA program, internal audits and root cause investigations
• Lead complaint investigations and keep the site cGMP compliant
• Keep the QMS aligned with FDA and ISO requirements
• Work with customers and suppliers on corrective actions and approvals
• Partner with Production on product reliability and inspection
• Spend real time on the plant floor with operators and supervisors

What you'll bring

• Bachelor's in chemistry or a life science (or equivalent experience)
• Must have: experience in a chemical manufacturing plant (such as salts, solvents, acids, or high-purity materials)
• 5+ years in quality systems within chemical, high-purity or FDA-regulated manufacturing
• Strong working knowledge of FDA and ISO quality system requirements
• People leadership experience, ideally in a unionised environment
• Proven plant quality leadership, with the presence to set the standard across a busy manufacturing site
• Medical, dental and vision
• 401(k) with company match and an employee stock purchase plan
• 6 weeks fully paid parental leave
• HSA/FSA, wellness programs and volunteer time off