Quality Leaders Sought for Top-Tier Medical Device Organization
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Job Description
We are seeking a seasoned quality professional to join our team as an Associate Director of Quality. This is a key leadership role within the organization, responsible for driving quality and regulatory compliance across our pharmaceutical products.
The successful candidate will be an expert in pharmaceutical quality and compliance, with a strong track record of delivering high-quality results in a fast-paced environment. They will provide functional leadership, including effective allocation and management of departmental resources, to meet business goals.
This role requires a deep understanding of pharmaceutical quality systems, regulatory requirements, and industry standards. The successful candidate will ensure that all quality system activities align with compliance requirements and organizational objectives.
Key Responsibilities
* Serve as a subject matter expert in pharmaceutical quality and compliance
* Provide functional leadership, including effective allocation and management of departmental resources
* Ensure all quality system activities align with compliance requirements and organizational objectives
* Lead audit teams and coordinate with cross-functional departments to address findings and implement effective corrective actions
* Act as a key interface with external regulatory bodies and support audits or inspections as needed
Requirements
To be considered for this role, you must have:
* A Bachelor's degree (Level 8) in Science or Engineering (Master's degree or higher, Level 9, is an advantage)
* 10+ years in pharmaceutical or biotech production, with a strong background in Quality Assurance (QA), Quality Control (QC), or Compliance
* At least 5 years in a managerial or leadership role in a quality-focused function
* Strong knowledge of cGMP, ICH standards, EU GMP Annexes, and FDA/HPRA requirements
Benefits
As a member of our team, you can expect:
* Opportunities for career growth and development
* A collaborative and supportive work environment
* Competitive compensation and benefits package