Manager, Quality Assurance Documentation

Grifols

QA Manager overseeing documentation and change control processes in a global healthcare company. Leading a team to ensure compliance in pharmaceuticals with an emphasis on quality assurance.

Posted 4/24/2026full-timeLos Angeles • California • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $135,000 per yearWebsite

About the role

Key responsibilities & impact

Manage QA Documentation Department and systems
Change Control Management and Document Management System
Ensure that all changes to documents, facility computer and packaging components are properly documented, justified and approved
Manage/supervise QA staff and ensure their growth/development through effective performance counseling and training
Oversee and provide direction in the maintenance of the change control system and Document management system
Review all change requests for clarity, purpose, justification and Regulatory requirements
Prepare information for annual reportable changes to be submitted to FDA
Routine reporting of document workflow status and upcoming/overdue procedures for periodic review
Evaluate and implement process and system improvement
Site representative as system owner for groups consisting of various Grifols sites for benchmarking and harmonization efforts
Ensure that product impacted by change is placed on hold
Responsible for design, development, revision of packaging and labeling
Maintain effective communication with management
Manage operational budget
Chair all change boards
Provide guidance and support to production on cGMP compliance
Provide support, direction and coaching to subordinate employees in the areas of the QA department
Participate in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.

Requirements

What you’ll need

BS degree in Biology, Chemistry, related Science or Engineering
5-8 years of experience in Quality Assurance
3-5 years working in pharmaceuticals
Supervisory experience
Knowledge of Regulatory requirements
Strong analytical, organizational and interpersonal skills
Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines.
Excellent written/verbal/leadership skills
Must be able lift, push or pull 50lbs

Benefits

Comp & perks

Medical
Dental
Vision
life insurance
PTO
paid holidays
up to 5% 401(K) match
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

QA Documentation ManagementChange Control ManagementDocument Management SystemcGMP complianceRegulatory requirementsProcess improvementPackaging designLabeling developmentPerformance counselingTraining

Soft Skills

Analytical skillsOrganizational skillsInterpersonal skillsLeadership skillsCommunication skills