Quality Systems Specialist

Actalent; United States; Hybrid; USD 76,000 - 83,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO / Vacation

Life Insurance (Voluntary)

Job summary

Actalent is seeking a Quality Systems Specialist to support the PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and aligning curricula with job roles and Quality System expectations. This hybrid Foster City, CA role requires on-site presence on Tue, Wed, and Thu.

The position involves partnering with SMEs, applying a risk-based approach to determine training needs, and optimizing curricula, while supporting LMS, records, and

Qualifications

• 6-8+ years of experience in a regulated pharmaceutical, biotech, or medical device environment, with direct experience in GxP training, Quality Systems, or compliance.
• Working knowledge of the pharmaceutical Quality System and GxP training requirements.
• Demonstrated ability to exercise independent judgment on training impact and compliance-driven learning decisions.
• Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.
• High attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.
• Effective communicator with the ability to influence and challenge stakeholders constructively using data-driven rationale.
• Working knowledge of LMS functionality, training data, and metrics.

Responsibilities

• Assess training impact for governance procedures with SMEs and Leaders.
• Apply risk-based approach to determine training requirements and delivery methods.
• Optimize curricula and role-based assignments to align with responsibilities.
• Translate learning strategy into compliant training deliverables with project managers.
• Serve as Training Subject Matter Expert advising on compliant training approaches.
• Analyze cross-functional training impacts and propose defensible solutions.
• Support LMS administration and use training data for continuous improvement.

Skills

GxP training

Quality Systems

LMS knowledge

Risk-based thinking

Data-driven decisions

Cross-functional collaboration

Tools

LMS

Job description

Job Title: Quality Systems Specialist

As a Quality Systems Specialist, you will support the PDM and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned with job roles and Quality System expectations. Your role will involve collaborating cross-functionally to translate learning strategy into effective, inspection-ready training deliverables that balance compliance and operational efficiency.

Responsibilities

• Partner with Subject Matter Experts (SMEs), Business Process Owners, and Functional Leaders to assess training impact for new or revised governance procedures.
• Apply a risk-based approach to determine training requirements, target audiences, and delivery methods.
• Assess and optimize training curricula and role-based assignments to ensure alignment with functional responsibilities and Quality expectations.
• Translate learning strategy into compliant training deliverables in collaboration with project managers and key stakeholders.
• Serve as a Training Subject Matter Expert, advising cross-functional partners on effective, compliant training approaches.
• Independently analyze complex, cross-functional training impacts and propose practical, defensible training solutions.
• Support the design and execution of site or functional training programs that meet compliance goals and support operational excellence.
• Assist in the development, maintenance, and governance of training content, records, and metrics in accordance with policies, procedures, and applicable regulations.
• Support administration and ongoing maintenance of the Learning Management System (LMS), including use of training data and metrics to inform decisions and continuous improvement.
• Coordinate training-related activities and projects within defined objectives and timelines.
• Proactively identify opportunities to improve training efficiency, learner experience, and overall training effectiveness.
• Provide additional training and quality support as directed by management.

Essential Skills

• 6-8+ years of experience in a regulated pharmaceutical, biotech, or medical device environment, with direct experience in GxP training, Quality Systems, or compliance.
• Working knowledge of the pharmaceutical Quality System and GxP training requirements.
• Demonstrated ability to exercise independent judgment on training impact and compliance-driven learning decisions.
• Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.
• High attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.
• Effective communicator with the ability to influence and challenge stakeholders constructively using data-driven rationale.
• Working knowledge of LMS functionality, training data, and metrics.

Additional Skills & Qualifications

• Experience in training development and instruction.
• Ability to partner with department heads and stakeholders to evaluate training plans.
• Customer service focus with a passion for supporting the needs of customers.
• Quality-minded and capable of making risk-based decisions.
• Ability to multitask and eagerness to learn.

Work Environment

The position offers a hybrid work environment, requiring on-site presence on Tuesdays, Wednesdays, and Thursdays.

Job Type & Location

This is a Contract position based out of Foster City, CA.

Pay and Benefits

The pay range for this position is $55.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 hybrid position in Foster City,CA.

Application Deadline

This position is anticipated to close on Oct 7, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby 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 [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.