Associate Director, Quality Assurance

Piramal Pharma Limited; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

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.

Skills

Leadership

Quality Assurance

Quality Systems

GxP knowledge

Regulatory readiness

Education

Bachelor's degree in a scientific discipline

Tools

SAP

TrackWise

Ensur

Job description

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

Associate Director, Quality Assurance

Job Description

The Associate Director, Quality Assurance provides leadership and oversight of Quality Operations supporting both Clinical and Commercial manufacturing activities at the Sellersville site. The role ensures compliance with cGMP requirements, data integrity standards, computer system validation requirements, and client and regulatory expectations.

• 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.

Key Stakeholders

Internal: Technical Operations, Supply Chain, Quality Control, Quality Systems, Engineering, Facilities, R&D, Project Management and Business Units. External: Commercial and Clinical Clients, FDA, EU and other regulatory agencies.

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.
• Other duties as deemed necessary.

Knowledge & Skills

• Strong leadership, communication and interpersonal skills.
• Expertise in QA, QC, Compliance and Quality Systems.
• Experience with SAP, TrackWise, Ensur and other GxP systems.
• Knowledge of regulatory requirements and inspection readiness.
• Strong attention to detail and problem-solving skills.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements.

Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.