Associate Director, Quality Management Systems

Company Overview:

SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.

Position Summary:

The Associate Director of Quality Systems is a critical role in delivering a Quality Management System (QMS) that enables innovation, productivity, continuous improvement, and adherence to applicable regulations. The Associate Director of Quality Systems will be responsible for building impactful relationships and collaborations across the organization while relying on practical experience to advance a proactive and quality beyond compliance strategy in a fast-paced organization.

Primary Responsibilities:

• Provide hands-on expertise in the day-to-day managing of data and document control including all aspects of issues management – change control, deviations, investigations, and CAPA
• Monitor the overall quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management and striving for operational excellence
• Actively participate in the preparation of Quality Management Reviews and Quality Improvement plans
• Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies and site procedures.
• Manage supplier qualification program including oversight of approved supplier list, performance of vendor audits, and continued monitoring of supplier performance.
• Participate in the management and execution of the internal audit program and client audit program including management of audit schedules, participation as lead auditor or host of client audits, and completion of follow-up actions as needed
• Maintain a GMP-compliant document management system
• Issue controlled documents in accordance with applicable procedures
• Collaborate with other subject matter experts across the organization to conduct cross-functional investigations, risk management and mitigation plans
• Represent Quality at designated cross-functional project/program team meetings
• Collect and analyze data to identify trends and detect problems and key issues
• Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Perform other duties as assigned
  
  

Education & Experience:

• Bachelor’s Degree in Life Sciences
• 10 years of relevant Quality experience including managing GXP quality systems in the Pharma/Biotech industry
• Significant experience with both digital and paper based QMS solutions
• Diverse, Quality operations experience across functions– including CRO/CDMO oversight activities
• Clinical and commercial experience
• Ability to utilize Risk Based approaches to prioritize and take appropriate actions
• Ability to work effectively in a team environment and build strong working relationships
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Strong organizational skills and the ability to multitask; can set priorities and follow a timeline
• Collaborates cross-functionally and can work independently with minimal functional oversight
• Ability to effectively operate across diverse cultures with strong stakeholder management and influencing skills
  
  

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Travel may be required to support business needs (5-25%, subject to change to support a growing business base)
• Must be able to lift up to 15 pounds at times.
  
  

Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.

SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.

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