Job Title: Document Control & Training Manager
Job Description
The Document Control & Training Manager supports the development, delivery, and maintenance of training programs related to document control and quality management systems. This role ensures that employees understand and follow document control processes, systems, and regulatory requirements, while also supporting audits and broader quality management initiatives. The position plays a key role in maintaining compliance with industry standards such as ISO, FDA, GMP, GDP, and EMA within a regulated environment, ideally in biotechnology or pharmaceuticals.
Responsibilities
- Design and create engaging training materials for quality management systems (QMS) and document control processes, tailored to different departments and sites.
- Deliver instructor-led and virtual training sessions to employees across multiple functions and locations.
- Provide onboarding training for new hires on document management practices and QMS procedures.
- Support change management initiatives by coaching and training teams impacted by process or system changes.
- Evaluate the effectiveness of training programs, gather feedback, analyze outcomes, and update content to ensure alignment with current industry standards and regulatory expectations.
- Maintain accurate and up-to-date training records, including completion status and competency assessments, to demonstrate compliance during audits.
- Create and manage curriculum assignments in the learning or training management system, ensuring the right training is assigned to the right roles.
- Generate and distribute training reports to stakeholders, summarizing completion rates, competency levels, and areas requiring improvement.
- Partner with cross-functional departments to provide first-line training support and continuously improve training programs based on business needs.
- Assist in the maintenance and continual improvement of the QMS to ensure ongoing compliance with GMP, FDA, EMA, ISO, GDP, and other relevant regulatory standards.
- Manage QMS documentation throughout its lifecycle, including the creation, review, revision, approval, issuance, and archival of standard operating procedures (SOPs), quality manuals, and other controlled documents.
- Ensure proper control, accessibility, and regular review of all QMS documents, maintaining high standards of documentation accuracy and compliance.
- Coordinate the implementation of change controls, ensuring systematic evaluation, documentation, and approval of changes that may affect the QMS.
- Analyze quality data from various sources, such as non-conformances, deviations, and corrective and preventive actions (CAPAs), to identify trends and areas for improvement.
- Generate detailed reports on QMS performance metrics, providing insights and recommendations to experience leadership to drive quality improvements.
- Monitor key performance indicators (KPIs) related to quality, including defect rates, audit findings, CAPA completion times, and other relevant measures.
- Assist in planning, conducting, and documenting internal audits to verify compliance with QMS requirements and applicable regulations.
- Support external audits conducted by regulatory agencies and clients by preparing documentation, coordinating responses, and participating in audit activities.
- Track and follow up on internal and external audit findings to ensure timely and effective implementation of corrective and preventive actions.
- Stay current with changes in regulatory requirements and industry standards and ensure that the QMS and related documentation are updated accordingly.
- Conduct periodic reviews of QMS documentation and processes to verify ongoing compliance with applicable regulations and internal policies.
- Participate in risk assessments related to quality processes and contribute to the development and implementation of risk mitigation strategies within the QMS framework.
- Identify opportunities to improve quality processes and the overall QMS, recommending and implementing enhancements to increase efficiency and effectiveness.
- Lead or participate in root cause analyses for quality issues, ensuring that appropriate corrective and preventive actions are identified, implemented, and monitored for effectiveness.
- Provide training and ongoing support to staff on QMS processes, regulatory requirements, and quality improvement initiatives.
- Collaborate closely with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, to ensure alignment on quality objectives and regulatory compliance.
- Work with Supplier Quality Management to ensure that suppliers meet defined quality standards and that the supply chain complies with GMP requirements.
- Communicate effectively with internal stakeholders to provide updates on QMS activities, audit results, training status, and continuous improvement initiatives.
- Review batch production records for completeness, accuracy, and compliance prior to product release, ensuring that all quality standards are met.
Essential Skills
- Demonstrated familiarity with regulatory standards such as ISO, FDA, GMP, and GDP.
- Proven experience with quality management systems (QMS), document control, and training in a regulated environment.
- Strong presentation and facilitation skills, with the ability to deliver both instructor-led and virtual training sessions.
- Excellent written and verbal communication skills, with the ability to convey complex quality and regulatory concepts clearly.
- Strong problem-solving abilities and a proactive approach to identifying and addressing challenges.
- Exceptional organizational skills and attention to detail, particularly in managing controlled documentation and training records.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
- Experience using Learning Management Systems (LMS) or training management platforms to assign, track, and report on training.
- Bachelors degree or an equivalent combination of education and experience.
- 35 years of experience in a regulated industry, preferably within biotechnology or pharmaceutical environments.
- Experience in project management, training, quality systems, or related fields.
- Hands-on experience with QMS, document control, and training functions, clearly reflected on the resume.
Additional Skills & Qualifications
- Experience in biotechnology or pharmaceutical industries, with a strong understanding of GMP environments.
- Exposure to EMA regulations and other international regulatory frameworks in addition to FDA and ISO standards.
- Experience supporting internal and external audits, including preparation of documentation and responses to findings.
- Familiarity with CAPA processes, non-conformance management, and deviation handling.
- Experience conducting or participating in risk assessments and implementing risk mitigation strategies.
- Experience in change control processes within a QMS, including evaluation and documentation of changes.
- Experience analyzing quality data and KPIs to drive continuous improvement initiatives.
- Ability to collaborate effectively with cross-functional teams such as Production, Quality Control, Regulatory Affairs, Supply Chain, and Supplier Quality Management.
- Comfort working in a fast-paced, highly regulated environment with evolving regulatory expectations.
- Strong interpersonal skills, with the ability to coach, influence, and support employees at all levels of the organization.
Work Environment
The role operates within a regulated quality-focused environment, likely in the biotechnology or pharmaceutical sector, with a strong emphasis on compliance with GMP, FDA, EMA, ISO, and GDP standards. The standard work schedule is Monday through Friday, 8:30 a.m. to 5:00 p.m., with occasional weekend work based on business needs. Work involves extensive interaction with quality management systems, controlled documentation, learning management systems, and standard office productivity tools such as Microsoft Office. The position requires close collaboration with cross-functional teams, including Production, Quality Control, Regulatory Affairs, Supply Chain, and Supplier Quality Management, as well as regular involvement in internal and external audits. The organization follows equal employment opportunity principles and provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable laws. The workplace is nicotine-free, meaning the use of nicotine productsincluding cigarettes, vaping devices, chewing tobacco, and other nicotine-containing substancesis prohibited on company property, and employees are expected to complete their full shift without using nicotine. The culture emphasizes a healthy, compliant, and continuous-improvement-oriented environment, with a structured interview process that typically includes multiple stages, such as discussions with human resources, hiring management, and experienced leadership.
Job Type & Location
This is a Contract position based out of Sacramento, CA.
Pay and Benefits
The pay range for this position is $50.00 - $55.00/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)
Job Type & Location
This is a Contract position based out of Sacramento, CA.
Application Deadline
This position is anticipated to close on Oct 30, 2026.
Workplace Type
This is a fully onsite position in Sacramento,CA.
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 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 actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
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