QA Manager - Patterson North Operations

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits from day 1

401(k) immediate vesting

Paid volunteerism

PTO 13 days

Wellness time off

Paid holidays

Competitive pay

Job summary

Grand River Aseptic Manufacturing (GRAM) is seeking a leader to direct Quality Systems with oversight of Aseptic Manufacturing operations. The role requires a life sciences degree and 8+ years in GMP settings, including 4 years in management.

You will author and review cGMP documents, NCR investigations, and SOPs, while coordinating with regulators and clients. Strong communication and leadership are essential to drive timely, compliant outcomes.

Qualifications

• Bachelor's degree in Life Sciences or related field and 8+ years of experience in a GMP manufacturing setting.
• 4 years of prior management/leadership experience in GMP manufacturing.
• Knowledge of Quality principles and cGMP/FDA standards.

Responsibilities

• Lead and oversee GRAM Quality Systems and aseptic manufacturing operations.
• Author, review, and revise cGMP documents, NCR investigations, and SOPs.
• Communicate with management, regulators, and clients in written and verbal form.
• Allocate resources, manage priorities, and drive improvements in a fast-paced environment.

Skills

Technical writing

Regulatory communication

Leadership

Project management

Education

Bachelor's degree in Life Sciences or related

Job 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!

Overview of this Position:

Provide direction and leadership of the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight of Aseptic Manufacturing operations.

Non-Negotiable Requirements:?

• Bachelor's degree in Life Sciences or a related field and/or a minimum of 8+ years related work experience
• 4 years of prior management / leadership experience required in a GMP manufacturing environment.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.

Preferred Requirements:

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

Responsibilities Include (but is not limited to):

• Strong technical writing and documentation skills, with the ability to clearly author, review, and revise cGMP documentation, NCR investigations, SOPs, and other quality documents in a highly regulated aseptic manufacturing environment.
• Ability to interpret and relate Quality standards for implementation and review.
• Ability to portray an appropriate level of integrity and professionalism at all times.
• Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
• Ability to complete tasks accurately and according to established timelines.
• Demonstrated management ability with a proven track record of leading teams to meet objectives.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Demonstrated high level of initiative with the ability to work independently, identify areas of improvement, and proactively drive solutions in a fast paced aseptic manufacturing environment.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion 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.