Pharmaceutical Quality Assurance Manager
Granulation Technology, Inc. (GTI) – Fairfield, NJ
Lead Quality. Protect Patients. Build the Future.
Granulation Technology, Inc. (GTI) is a growing pharmaceutical manufacturer of generic prescription and OTC drug products. We are seeking an experienced, hands-on Quality Assurance Manager who will lead our Quality Management System, strengthen our quality culture, and help prepare our organization for continued growth.
This is a leadership position for someone who enjoys solving complex quality problems, improving systems, mentoring employees, and ensuring every product meets the highest standards of safety, quality, and regulatory compliance.
What You’ll Do
- Lead and maintain the Pharmaceutical Quality Management System (QMS)
- Review and approve batch production records and disposition of finished products
- Lead investigations involving deviations, OOS, complaints, nonconformances, and CAPAs
- Manage change control, document control, training, and quality metrics
- Prepare for and participate in FDA, customer, and regulatory inspections
- Partner with Production, QC, Warehouse, and Regulatory Affairs to drive continuous improvement
- Develop practical solutions that improve compliance without creating unnecessary bureaucracy
- Mentor and develop QA staff while promoting a culture of accountability and continuous improvement
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field (advanced degree is a plus)
- 7+ years of Quality Assurance experience in FDA-regulated pharmaceutical manufacturing
- At least 3 years in a leadership or supervisory role
- Strong knowledge of FDA cGMP (21 CFR Parts 210 & 211)
- Experience with batch record review, investigations, CAPA, change control, supplier qualification, document control, and internal audits
- Experience participating in FDA inspections
- Excellent analytical, communication, and leadership skills
We’re Looking for Someone Who…
- Thinks critically and investigates problems thoroughly
- Has high ethical standards and the confidence to make difficult quality decisions
- Leads by example and earns respect from production and technical teams
- Believes quality is everyone’s responsibility—not just QA’s
- Is organized, proactive, and committed to continuous improvement
Preferred Experience
- Generic pharmaceutical (ANDA) manufacturing
- OTC drug manufacturing
- Solid oral dosage forms (tablets and capsules)
- Electronic Quality Management Systems (eQMS)
- Risk management and quality metrics
Why GTI?
- Opportunity to build and improve quality systems in a growing pharmaceutical company
- Direct impact on regulatory compliance and product quality
- Collaborative leadership team
- Competitive salary in the range of $70,000–$80,000, along with performance bonus and benefits
- Long-term career growth opportunities
Application Process
Qualified candidates will participate in:
- Technical Quality Assurance interview
- Practical quality assessment (batch record and investigation review)
- Leadership interview
- Reference and background verification
If you are passionate about pharmaceutical quality and want to make a meaningful impact in a growing organization, we’d like to hear from you.
Pay: $70,000.00 - $80,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
Application Question(s):
- How many years of Quality Assurance experience do you have in FDA-regulated pharmaceutical manufacturing?
Less than 3 years
3–5 years
5–7 years
7–10 years
More than 10 years
- How many years have you worked in a supervisory or management role?
None
Less than 2 years
2–5 years
More than 5 years
- Which pharmaceutical dosage forms have you worked with? (Select all that apply.)
Tablets
Capsules
Powders
Liquids
Topicals
Sterile products
Other
- Have you reviewed and approved batch production records?
Yes
No
- Have you led deviation investigations and CAPA activities?
Yes
No
- Have you participated in an FDA inspection?
Yes, as a primary QA representative
Yes, as part of the QA team
No
- Which quality systems have you managed? (Select all that apply.)
Deviations
CAPA
Change Control
OOS/OOT Investigations
Complaints
Supplier Qualification
Internal Audits
Training
Document Control
- Have you worked with generic pharmaceutical (ANDA) products?
Yes
No
- Have you worked with OTC drug products?
Yes
No
- Are you legally authorized to work in the United States?
Yes
No
- Will you now or in the future require employer sponsorship for employment?
Yes
No
Work Location: In person
