Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Senior Manager of Quality Assurance Operations provides direction and leadership to Quality Systems with oversight of the Quality Assurance Functions supporting Finishing Operations at our Godfrey and Patterson facilities (inspection, labeling and packaging), Incoming Material operations, Technical Support and Batch Release. This position works closely with all levels of the Operations (Manufacturing, Finishing, Warehouse), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Supply Chain, Business Development, and Finance teams.

Non-Negotiable Requirements:

• Bachelor’s Degree in Life Sciences or a related field and/or a minimum of 10-12+ years related work experience.
• At least 5 years of prior management/leadership experience.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Experience and expertise in aseptic manufacturing of regulated products is preferred.
• Prior experience interacting with regulatory.

Responsibilities Include (but are not limited to):

• Provide leadership to Quality Assurance Managers/Supervisors, QA Specialists, and QA Technicians. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
• Ensure Quality Assurance support and oversight of the above GRAM Operations across all shifts, including weekend support.
• Ensure Quality Assurance support and oversight of project work, including tech. transfer/client-based projects; including documentation in support of continuous improvement projects.
• Review and approval of non-conformance reports, including deviations, laboratory/OOS investigations.
• Oversight and management of Material and Batch Review/Release systems.
• Client support/interaction related to these processes.
• Interface with auditors, including client representatives and regulatory agencies.
• Perform Quality Assurance review and approval of cGMP documents.
• Support Agency, customer and vendor audits as needed.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

PAID HOLIDAYS: We offer 8 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process. Shift differential available for second and third shift!