Annual Product Quality Review Program Lead (Pharmaceutical)

Location: Onsite office/laboratory position in Monmouth Junction, New Jersey, United States

Salary: $100,000–$145,000 annually, plus potential bonus

Company

hirify.global is a privately owned U.S. biopharmaceutical company developing and commercializing medicines for ADHD, spectrum disorders, anxiety, pain, addiction, and other therapeutic areas.

What you will do

• Lead the collection, aggregation, statistical trending, and drafting of Annual Product Quality Reviews and Annual Product Reviews.
• Evaluate manufacturing, packaging, laboratory, complaint, deviation, CAPA, change control, and stability data to identify process variability and emerging quality risks.
• Apply control charts, process capability analysis, regression, Pareto analysis, trend modeling, ANOVA, and other statistical methods.
• Assess critical quality attributes, critical process parameters, Cpk/Ppk indicators, and continued process verification data.
• Lead APR risk assessment meetings and collaborate with QA, Production, Laboratory, Technical Services, SMEs, and external stakeholders.
• Support root cause investigations, revalidation decisions, regulatory inspections, and FDA and foreign health authority audits as the APQR and process statistics SME.

Requirements

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline, plus at least 5 years of relevant pharmaceutical or biotechnology experience, or an equivalent combination.
• Deep knowledge of FDA 21 CFR Parts 210/211 and ICH Q8, Q9, and Q10.
• Experience with process validation, including Stage 1, Stage 2, and Stage 3 Continued Process Verification.
• Proficiency with statistical analysis platforms such as Minitab, JMP, or SAS and with Microsoft Office.
• ASQ Certified Quality Engineer or Certified Quality Auditor certification required.
• Fluent English in verbal and written communication is required. Ability to work onsite in an office/laboratory environment, use PPE, stand for extended periods, lift up to 30 lbs, distinguish colors, and work additional hours when needed.

Nice to have

• Experience with oral solid, liquid, delayed-release, or extended-release dosage manufacturing.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with Power BI, Tableau, JMP Live, Spotfire, or equivalent data visualization and reporting tools.

Culture & Benefits

• Collaborative, respectful, open, and honest communication in a matrixed environment.
• Medical, dental, vision, prescription, life insurance, and 401(k) with company match.
• Bonus eligibility, paid company holidays, paid time off, and paid volunteer time.
• Employee Resource Groups and support for a diverse workforce.
• No travel required; stated travel requirement is 0%.