Director, Computer System Quality Team Lead (AI)

Location: Hybrid role based in Collegeville, Pennsylvania, United States; candidates must have permanent U.S. work authorization. U.S. work visa sponsorship is not available. Occasional business travel and meetings outside standard working hours may be required.

Annual base salary: $176,600–$294,300, plus a 20% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global develops medicines and operates global Quality, Digital, and regulated manufacturing and distribution organizations.

What you will do

• Define and advance risk-based Computer System Assurance strategies across PGS sites and Digital organizations.
• Serve as the Quality authority for the Digital process framework and provide decisions on complex system risk assessments, classifications, and assurance approaches.
• Establish quality oversight for GMP/GDP enterprise Digital, artificial intelligence, and federated solutions throughout their life cycles.
• Lead the Level 2 Computer System Assurance process, including governance, adoption, continuous improvement, change management, metrics, and inspection support.
• Lead portfolio-level audit and inspection readiness, investigations, compliance escalations, and corrective or preventive action recommendations.
• Partner with Quality, Digital, artificial intelligence, governance, risk, compliance, process-owner, and business stakeholders while advising senior leaders.

Requirements

• Bachelor’s degree in a scientific, engineering, technology, data, quality, or related discipline with at least eight years of relevant experience; or a master’s degree with at least seven years; or a doctoral degree with at least five years.
• Significant experience in computerized-system quality, Computer System Assurance, or computerized-system validation in a GMP/GDP or similarly regulated environment.
• Expertise in risk-based assurance, validation, quality-risk management, and ongoing management of regulated computer systems.
• Experience leading a significant quality process, including maintenance, adoption, continuous improvement, and inspection support.
• Experience leading complex cross-functional initiatives in a global, highly matrixed organization and representing Quality during regulatory inspections, internal audits, or inspection-readiness activities.
• Ability to exercise independent judgment, develop defensible recommendations for complex and ambiguous matters, and influence senior leaders and stakeholders without direct authority.
• Strong written and verbal communication skills, including translating technical assurance matters into clear quality, risk, and business implications.
• Ability to evaluate multiple complex inputs, manage competing priorities, and operate effectively in a complex, matrixed, globally distributed environment.

Nice to have

• Advanced degree or certification in quality, auditing, risk management, Digital, or computerized-system assurance.
• Experience providing Quality authority or strategic guidance across multiple business units, sites, or Digital portfolios.
• Experience applying GAMP 5, ICH Q9, EU Annex 11, 21 CFR Part 11, and other relevant computerized-system requirements.
• Experience with assurance for artificial intelligence, automation, cloud-based, or federated Digital solutions.
• Experience establishing system monitoring, periodic review, or portfolio-scale inspection-readiness practices.
• Experience applying IMEx, Lean, Six Sigma, or comparable continuous-improvement methods, and using data, monitoring tools, or automation to improve assurance effectiveness.

Culture & Benefits

• Full-time employment in a global, highly matrixed, and globally distributed environment.
• Benefits include a 401(k) with hirify.global matching and additional retirement contributions, paid vacation, holidays, personal days, caregiver/parental and medical leave, and medical, prescription, dental, and vision coverage.
• Work location is hybrid; relocation support is stated as unavailable in the work-location section, while assistance may be available based on business needs or eligibility.
• Periodic global-stakeholder meetings may occur outside standard working hours, with occasional business travel.