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Senior Quality Assurance Manager
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Job Title: Senior Quality Assurance Manager
We are seeking a highly skilled professional with expertise in managing supplier quality, driving strategic initiatives and building partnerships.
The role involves ensuring suppliers meet regulatory standards by leading audits and implementing quality improvement programs.
Key Responsibilities:
- Develop and implement supplier quality strategies and policies.
- Lead supplier qualification, selection and approval processes in alignment with regulatory requirements.
- Conduct supplier audits, assessments and performance reviews to ensure compliance with quality and regulatory requirements.
- Oversee corrective and preventive actions (CAPA), root cause analysis and continuous improvement programs.
- Collaborate with cross-functional teams to resolve supplier-related issues.
- Monitor supplier KPIs and drive improvement initiatives.
- Support new product development by ensuring supplier capability for components and raw materials.
- Manage change control processes and evaluate the impact on product quality and regulatory compliance.
- Train and guide internal teams and suppliers on quality systems and compliance expectations.
- Ensure alignment with global regulatory requirements.
Required Skills & Qualifications:
- Strong expertise in supplier quality management, auditing and regulatory compliance.
- Proficiency in risk management, root cause analysis, CAPA and Lean methodologies.
- Excellent communication, negotiation and stakeholder management skills.
- Ability to lead supplier development programs and strategic quality initiatives.
- Experience in global supplier management and multicultural environments.
Preferred Qualifications:
- Bachelors/Masters degree in Engineering, Life Sciences or related field.
- 10+ years of experience in supplier quality assurance, preferably in regulated industries.
- Certified Lead Auditor (ISO 9001/13485, GMP or equivalent) preferred.
A proven track record of delivering measurable quality improvements and managing global suppliers.
