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Associate Director, Quality Assurance - Change Control
$135,500 - $213,400/Yr
Merck KGaA Darmstadt Germany - Wilson, NC
posted 2 months ago
Full-time - Mid Level
Onsite - Wilson, NC
Chemical Manufacturing
About the position
The Associate Director, Quality Management System Change Control is responsible for overseeing and improving the Change Control Quality Management System (QMS) within the pharmaceutical industry. This role involves collaboration with various stakeholders to ensure compliance with regulations, enhance processes, and provide training. The position requires a strong leader with experience in good manufacturing practices and change control systems.
Responsibilities
- Monitor health authority regulations and ensure incorporation into the change control QMS documents.
- Author and maintain global change control topic documents.
- Ensure procedures align with other QMS topics and IT platform updates.
- Support development and deployment of new or enhanced Change Management processes and systems.
- Interact with Batch Disposition personnel and regulatory scientists to integrate processes with change control.
- Develop and maintain global training materials and deliver training to Manufacturing Division personnel.
- Lead a community of practice for Change Control and manage content on the CoP's website.
- Network with functional groups to provide subject matter expertise and implement best practices.
- Troubleshoot network change control issues and provide guidance on resolution.
- Interface with IT to identify system improvements for the change control process.
Requirements
- B.Sc. in a relevant field of science or engineering.
- Minimum 5 years in pharmaceutical and/or vaccine manufacturing environment.
- Experience with Change Control and IT systems enabling change control (e.g., Veeva, IPI, Trackwise).
- Continuous improvement mindset and bias to action.
Nice-to-haves
- Background in US and international GMP policy and regulations.
- Demonstrated personnel management/leadership skills.
- Demonstrated project management/leadership skills.
- Strong communication skills.
- Working knowledge in Quality Risk Management tools and principles.
- Working knowledge of SAP or other relevant ERP systems.
Benefits
- Bonus eligibility
- Long term incentive if applicable
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Sick days
