Quality Assurance Compliance Manager
6 days ago
Quality Assurance & Compliance Manager
Join a leading CDMO in the life sciences sector as a Quality Assurance & Compliance Manager
Are you passionate about quality, compliance, and making a real impact in a dynamic, growth-oriented environment? We're seeking a skilled professional to lead and uphold high standards in quality assurance and regulatory compliance for pharmaceutical and specialty products.
Key Responsibilities:
- Develop, implement, and maintain quality standards and systems.
- Oversee audits, investigations, and regulatory inspections.
- Manage compliance activities with suppliers and partners.
- Lead internal and external audits; ensure adherence to cGMP and regulatory requirements.
- Review and approve documentation, SOPs, and batch records.
- Support product quality, customer complaints, and regulatory filings.
- Conduct training and drive continuous improvement in quality processes.
Qualifications:
- Bachelor's degree in life sciences or related field.
- 8+ years of QA management experience in biotech/pharma; CDMO experience preferred.
- Strong knowledge of global GMP requirements and quality management systems.
- Excellent communication, organizational, and IT skills.
- Willingness to travel occasionally.
Please note:
Visa sponsorship is not offered.
Relocation assistance may be offered for this position.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
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