Senior QA Leader — Associate Director, Quality Assurance

Piramal Pharma Limited

Northern (KY)

Hybrid

USD 120,000 - 160,000

Full time

10 days ago

Application generator

Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.

Get past ATS filters

Job summary

Piramal Pharma Limited is seeking an Associate Director, Quality Assurance to lead QA operations across clinical and commercial manufacturing. You will ensure compliance with cGMP, data integrity, and regulatory expectations while overseeing deviations, CAPAs and change controls.

You’ll interact with clients, regulators, and internal teams to drive quality metrics and audits. The role requires a strong background in oral solid dosage, CDMO experience is preferred, and leadership of

Qualifications

Bachelor's degree in a scientific discipline preferred.
Minimum 10 years of progressive quality experience in a regulated cGMP environment.
Minimum 3 years of people leadership experience.
Experience in oral solid dosage manufacturing required.
CDMO experience preferred.

Responsibilities

Lead Quality Operations, Clinical Operations, Commercial Operations, Data Auditing and QA IT support.
Provide oversight of deviations, CAPAs and change controls.
Review and approve GMP documentation including batch records, SOPs, protocols and validation documents.
Serve as primary quality contact for clients and support project meetings.
Develop and monitor operational quality metrics and KPIs.
Support audits and inspections by customers and regulatory agencies.
Oversee staffing, capacity planning, cross-training and talent development.
Manage supplier quality activities, annual product reviews and departmental budgets.
Ensure compliance with 21 CFR Part 11, Annex 11 and GAMP 5 requirements.
Act as designee for Quality leadership as needed.