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Job Title: QMS Specialist (25/hrs. per week)

We are seeking a highly skilled QMS Specialist with experience in a GMP-regulated environment, ideally within biotech, cell/gene therapy, or pharmaceuticals. The ideal candidate will have strong expertise in Quality Management Systems, including deviation management, CAPA resolution, change control, and document management. This role requires an individual who is execution-oriented, with the ability to identify and resolve gaps efficiently and effectively. In-depth knowledge of FDA, EMA, and ICH regulations for GMP compliance is essential.

Responsibilities

+ Assess current QMS processes, identify areas for improvement, and implement effective solutions to ensure compliance with GMP and regulatory requirements.

+ Own and drive activities related to document control, change management, deviation handling, and CAPA implementation.

+ Work cross-functionally to ensure supplier and contract testing lab compliance, executing qualification processes as needed.

+ Assist in the release of GMP materials by ensuring quality oversight and compliance with internal and external regulatory expectations.

+ Support internal and external audits, prepare documentation, and ensure adherence to FDA, EMA, and ICH guidelines.

+ Proactively develop and implement strategies to enhance the efficiency and effectiveness of the Quality Management System.

+ Assist in developing training programs and ensuring QMS adherence across teams.

Essential Skills

+ Strong hands-on experience in Quality Management Systems, including deviation management, CAPA resolution, change control, and document management.

+ Proven ability to identify gaps and take action to resolve them efficiently and effectively.

+ In-depth understanding of FDA, EMA, and ICH regulations for GMP compliance.

+ Proficiency with electronic QMS platforms such as Veeva, MasterControl, or TrackWise.

+ Ability to analyze root causes, develop practical solutions, and drive implementation.

+ Strong communication and collaboration skills to work cross-functionally and liaise with internal teams, CMOs, and suppliers.

Additional Skills & Qualifications

+ Experience with quality management systems, quality auditing, and QMS implementation.

+ Program management skills, specifically in optimizing quality systems, process mapping, and auditing.

+ Experience with SharePoint for document management and collaboration.

Work Environment

This position is remote, offering flexibility and the opportunity to work from your preferred location.

Pay and Benefits

The pay range for this position is $80.00 - $110.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.