Sr. Manager, QA Technical Support

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 provides direction and leadership to Grand River Aseptic Manufacturing (GRAM) Quality Technical Support team with oversight of both internal and external projects, including the on-boarding of new clients / client projects. 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
• Thorough understanding of cGMP, FDA guidelines and multinational regulatory standards
• Must have 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 authorities is preferred

Responsibilities Include (but are not limited to):

• Provide leadership to Quality Assurance Specialists at various levels. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
• Foster long term relationship with customers based on delivering quality, service and value to customers (both internal and external).
• Provide leadership to project teams to ensure that project deliverables meet all regulatory and industry best practice standards and project schedules, requirements and deliverables, and ensuring project-related tasks assigned to Quality Assurance are delivered according to project schedules.
• Provide Quality input for new technical transfers, including review of RFPs, cost estimates, project plans, etc.
• Work closely with the Change Management process and process owner to ensure all project-related deliverables are aligned with and delivered according to change plans and implementation requirements.
• Oversee implementation of internal continuous improvement projects.
• Identify opportunities/risks and develops/implements solutions to improve quality of customer product, service being administered, department operations and/or costs.
• Oversight of Quality Assurance review and approval of all cGMP documentation in support of both GRAM and client-driven projects, as needed, including procedures, test methods, master batch records, risk assessment reports, validation documents (master plans, protocols, studies, summary reports, requirements documents, etc.)
• 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 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.