What are the responsibilities and job description for the Quality Assurance Manager position at Planet Pharma?
The Quality Assurance Manager supports and strengthens the site’s Quality function by ensuring that all operations comply with GMP, regulatory requirements, internal quality standards, and customer expectations. Working closely with the Director of Quality, this role oversees day to day Quality Assurance (QA) activities depending on the organization’s structure. The Quality Assurance Manager drives continuous improvement, maintains a strong quality culture, and ensures the consistent manufacture of safe, effective pharmaceutical products.
Areas of responsibility
Quality System Oversight
- Lead the Regulatory and External Customer Audits including preparation, execution and follow-up.
- Maintain and continuously improve the site’s Quality Management System (QMS) in alignment with ISO 9001, ISO 15378, and other applicable regulations.
- Oversee deviation management, CAPA, change control, complaints, and risk assessments, escalating critical issues to the Director of Quality.
- Ensure timely and compliant batch record review and product release processes.
Compliance & Documentation
- Ensure all GMP documentation is accurate, complete, and maintained according to data integrity principles
- Review and approve SOPs, validation protocols/reports, and quality-related technical documents.
- Provide regular compliance updates and quality metrics to the Director of Quality.
- Monitor compliance trends and implement corrective actions where needed.
Leadership & Team Management
- Manage and develop QA staff, providing coaching, training, and performance evaluations.
- Collaborate with the Director of Quality to set departmental goals, allocate resources, and align quality initiatives with site strategy.
- Foster a culture of quality, accountability, and continuous improvement across the organization.
- Collaborate cross-functionally with Production, Engineering, Supply Chain, and R&D.
Continuous Improvement
- Lead quality improvement initiatives using tools such as Lean, Six Sigma, and root cause analysis.
- Identify opportunities to streamline processes while maintaining compliance.
- Track and report quality KPIs to senior leadership.
Manufacturing & Process Support
- Provide quality support for manufacturing processes.
- Lead process validations (IQ, OQ, PQ) and maintain validation documentation.
- Participate in FMEA, Control Plans, and risk management activities.
- Support containment, investigation, and resolution of nonconformities.
New Product Introduction (NPI)
- Support quality planning and risk assessments for new products and transfers.
- Review customer specifications, drawings, and validation requirements.
- Ensure quality deliverables are completed on time for project milestones.
Supplier & Customer Quality
- Support supplier qualification, audits, and performance monitoring.
- Investigate customer complaints and ensure timely, compliant responses.
- Collaborate with customers to resolve quality issues and improve satisfaction.
Experience and Education Requirements
Bachelor’s Degree required. Science or engineering-related field a plus
- 5-7 years of relevant work experience, in a Q Manager/Engineer role (Preferably in a pharmaceutical packaging environment.)
- Thorough knowledge of cGMP regulations and current industry practice
- Knowledge of ISO 9001 and ISO 15378
Salary Range: $120,000 to $140,000/yr* Based on experience
Salary : $120,000 - $140,000