QA Systems and Document Control Manager

• 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 MasterControl or equivalent platforms.

Include (but are not limited to):

• 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.

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.

If you meet the required criteria listed above, GRAM welcomes you to apply today!