Director, Commercial QCA

The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations. The role will oversee laboratory testing, method development and validation, and stability studies, and ensure compliance with Quality System, GMP, and regulatory requirements.

Requirements

• Bachelor’s degree in biology, chemistry, or other scientific related field
• 15 years of related quality experience with 8+ years at the management level required
• Master’s degree in biology, chemistry, or other scientific related field with 10 years of related quality experience
• Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience
• Extensive experience with assay qualification, validation, and transfer activities required
• Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome required

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays, Exempt Employees are eligible for Unlimited PTO, Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day