Quality Assurance Compliance Specialist
Location: Bethlehem, Pennsylvania, United States
Business Unit: Piramal Critical Care (PCC)
Department: Quality Assurance
Job Overview
Piramal Critical Care (PCC) is seeking a Quality Assurance Compliance Specialist to support regulatory compliance, quality systems oversight, and audit readiness at its Bethlehem, PA manufacturing site. This role plays a critical part in ensuring adherence to FDA, cGMP, and global regulatory standards within a highly regulated pharmaceutical manufacturing environment.
The ideal candidate will have hands-on experience in quality assurance, compliance management, and regulatory inspection support within the pharmaceutical or life sciences industry. This position offers the opportunity to contribute to global hospital generics and critical care product compliance programs.
Key Responsibilities
Ensure compliance with US FDA regulations, cGMP guidelines, and global regulatory requirements.
Support internal and external audits, including FDA and other regulatory inspections.
Review and approve quality system documentation including deviations, change controls, CAPAs, and investigations.
Monitor quality metrics and support continuous improvement initiatives.
Perform compliance gap assessments and risk evaluations.
Assist in maintaining site inspection readiness at all times.
Support data integrity initiatives and ensure adherence to ALCOA+ principles.
Collaborate with cross-functional departments including Manufacturing, QC, Regulatory Affairs, and Supply Chain.
Contribute to SOP development, revision, and training related to compliance processes.
Minimum Qualifications & Experience
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related discipline.
Minimum 3–6 years of experience in Quality Assurance or Compliance within a pharmaceutical, biotech, or regulated manufacturing environment.
Strong working knowledge of cGMP, FDA regulations, and global compliance standards.
Experience supporting regulatory audits and responding to inspection observations.
Familiarity with quality management systems (QMS), deviation management, CAPA, and change control processes.
Strong documentation, analytical, and communication skills.
Preferred Competencies
Experience in sterile manufacturing or critical care pharmaceutical products.
Knowledge of data integrity principles and regulatory expectations.
Ability to work effectively in cross-functional global teams.
Strong problem-solving and risk assessment capabilities.
About Piramal Critical Care (PCC)
Piramal Critical Care (PCC), a part of Piramal Pharma Limited, is a leading global manufacturer of hospital generics and one of the world’s largest producers of inhaled anaesthetics including Sevoflurane, Isoflurane, and Halothane. PCC also offers Intrathecal Baclofen therapy for spasticity management.
With operations across the United States, Europe, and more than 100 countries worldwide, PCC operates state-of-the-art manufacturing facilities approved by the US FDA, UK MHRA, and other global regulatory authorities. The organization is committed to delivering high-quality critical care solutions while maintaining strong compliance, operational excellence, and patient safety standards.
Equal Employment Opportunity
Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. All employment decisions are based on merit, qualifications, and business needs without discrimination on legally protected grounds. The company is committed to fostering a diverse and inclusive workplace and provides reasonable accommodations where applicable.
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