Senior Specialist, External Quality Systems

$101,100 - $159,100/Yr

Merck KGaA Darmstadt Germany - Wilson, NC

Full-time - Mid Level

Onsite - Wilson, NC

Chemical Manufacturing

About the position

The role is an individual contributor position focused on ensuring compliance of External Quality Assurance (EQA) processes with approved quality manual documents and company policies. The incumbent will be part of the EQA QRM CoE within the EQA Compliance/System team, providing quality oversight of quality and business processes related to Quality Risk Management. Responsibilities include supporting the development and enhancement of critical processes and systems, compiling and analyzing metrics, and ensuring robust quality systems that comply with regulations governing material manufacturing.

Responsibilities

• Serve as Quality Subject Matter Expert (SME) for EQA.
• Maintain and provide expertise on EQA quality and business systems, tools, data, and processes.
• Ensure compliance with established policies and governmental regulations (GMP, etc.).
• Support the implementation of new quality systems and improvements.
• Assist in the development and execution of Quality Systems.
• Establish new or improved processes, tools, and systems across EQA.
• Compile, analyze, and report metrics, identifying trends and root causes.
• Support audit/inspection readiness and participate in regulatory quality report-outs.
• Provide project management support for EQA initiatives.
• Assist in preparing Quality Senior Management presentations.

Requirements

• Bachelor of Science (BS) degree in Science, Engineering, or related area with five years of experience in the Pharmaceutical/Biotechnology industry, or a Master of Science (MS) degree with three years of experience.
• Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control, including global GMP Quality and regulatory requirements.
• Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.

Nice-to-haves

• BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred.
• Prior management experience preferred.
• Moderate level of contractual and financial awareness.
• Previous experience supporting regulatory inspections.
• Strong project management skills.
• Experience with Quality Risk Management, External Entity Oversight, and Quality Management System.

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