QA Systems and Document Control Manager

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do?

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!

The QA Systems and Document Control Manager provides leadership and oversight of Document Control and Quality Systems to ensure compliance with cGMP requirements, quality standards, and regulatory expectations. Manages the lifecycle of controlled documentation, including document creation, revision, approval, and maintenance. Oversees key Quality Management System processes, including Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Management. Serves as a Subject Matter Expert (SME) to drive process effectiveness, continuous improvement, and compliance across the organization.

Partners cross-functionally with all departments to support manufacturing and quality objectives.

• Bachelor’s degree in Life Sciences or a related field and/or 5–10+ years of experience in Quality, Technical Operations, Continuous Improvement, or a related function within the pharmaceutical, biopharmaceutical, biotechnology, or manufacturing industry.
• Strong knowledge of cGMP regulations, FDA requirements, pharmaceutical manufacturing processes, and Quality Assurance principles.
• Experience with process improvement methodologies, including Lean and Six Sigma, and proficiency in Root Cause Analysis (RCA) tools and investigation techniques (e.g., 5 Whys, Fishbone).
• Demonstrated success leading cross-functional teams and driving quality and compliance initiatives across multiple organizational levels
• Experience with electronic Quality Management Systems (eQMS), such as Master Control or equivalent platforms.

• Strong knowledge of quality systems, cGMP regulations, and regulatory requirements, with the ability to interpret and apply quality standards across the organization.
• Proven leadership and people management skills, including coaching, mentoring, developing teams, and driving accountability.
• Excellent written, verbal, and presentation skills, with the ability to effectively communicate and influence stakeholders at all levels.
• Strong organizational, analytical, and problem-solving abilities, with demonstrated success managing multiple priorities and meeting deadlines in a fast-paced environment.
• Ability to lead cross-functional initiatives, build collaborative relationships, and drive alignment toward quality and business objectives.
• Results-oriented professional with a continuous improvement mindset and experience implementing process improvements to enhance compliance, efficiency, and effectiveness.
• Demonstrates high levels of integrity, professionalism, sound judgment, urgency, and customer focus.

Full job description available during formal interview process.

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!

GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

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!

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

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

Depends on Experience and is discussed during the interview process.