Quality Management Specialist

Job Title: Quality Management Specialist

Job Description

As a Quality Management Specialist, you will play a key role in driving and supporting the Site Quality Management System (QMS) metrics. Your focus will be on optimizing Quality Assurance (QA) processes to strengthen the organization’s quality culture. You will ensure regulatory compliance by effectively integrating requirements into the QMS and proactively communicating expectations across the site.

Responsibilities

• Conduct and support internal audits at the site.
• Plan and deliver Good Documentation Practice (GDP) training sessions as needed.
• Provide strategic oversight and practical management of Good Clinical Practice (GCP) activities to maintain regulatory compliance.
• Lead regulatory inspections, including preparation, execution, and follow-up.
• Assist with planning, conducting, reporting, and follow-up of GCP audits.
• Manage core QMS programs, including Deviations, CAPAs, Change Control, Document Requests, Document Change Controls, and Audit Reports.
• Ensure timely periodic review of controlled documents by notifying document owners.
• Monitor and support Key Quality Performance Indicators to promote operational excellence.
• Act as a QA resource, offering guidance and input to cross-functional teams.
• Perform study audits to verify compliance with internal procedures and regulatory standards.
• Provide recommendations for corrective and preventive actions based on audit findings.
• Develop, implement, and maintain the site’s quality system.
• Author, review, and approve SOPs to ensure alignment with regulatory requirements.
• Collaborate with functional managers during new employee onboarding.
• Participate in change control processes to assess and implement changes appropriately.
• Interpret regulatory requirements and provide clear guidance to stakeholders.
• Support planning and execution of customer audits related to clinical projects.
• Ensure root causes are identified and effective corrective actions are implemented.
• Review Continuous Improvement proposals for potential GxP impact.
• Build strong professional relationships with project teams and customers.
• Coach and mentor QA clinical personnel to foster growth and compliance awareness.

Essential Skills

• Quality Assurance and Quality Management
• Document Control and QMS Administration
• Compliance and Regulatory Knowledge
• Training Delivery
• GxP Expertise
• Auditing and Inspection Support
• Auditing

Additional Skills & Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacology, or related field).
• 2–5 years of experience in life sciences quality or a regulated environment.
• Strong knowledge of QMS, GCP, ICH Guidelines, ICH Q9, 21 CFR Part 11, Data Integrity, Risk Management, and Quality by Design principles.
• Experience conducting internal audits and hosting client audits.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively across cultures and cross-functional teams.
• Strong interpersonal skills with a customer-focused approach.
• Ability to work independently, prioritize tasks, and thrive in a fast-paced environment.

Work Environment

This is an onsite role within a dynamic and collaborative setting. The organization values innovation, continuous improvement, and teamwork, encouraging individual contributions to overall success.

Job Type & Location

This is a Permanent position based out of Miami, Florida.

Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for next steps.

Pay and Benefits

The pay range for this position is $75000.00 - $95000.00/yr.

Paid Time Off - retirement fund
We provide a wide range of benefits and programs to support your physical and mental health and wellbeing, some of which can be extended to include your families to ensure they are also supported

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on Oct 31, 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.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $75,000 - $95,000