Grifols · 7 hours ago
Regulatory Compliance Associate
Los Angeles, CA
Full-time
Onsite
Mid, Senior Level
$74K/yr - $85K/yr
5+ years expGrifols is a global healthcare company dedicated to improving health and well-being since 1909. The Regulatory Compliance Associate will support internal and supplier audits, participate in regulatory inspections, and ensure compliance with internal processes through corrective actions and training.
BiotechnologyHealth CareManufacturing
Responsibilities
Support internal cGxP audits
Support domestic and international supplier audits
Participate in customer, third party, and national or international regulatory agency audits. Prepare quality agreements
Prepare reports
Support and/or perform internal and GLP compliance audits of GB's manufacturing, testing and warehouse facilities and operations
Support and/or perform cGMP and GLP compliance audits of GB's suppliers and contract laboratories. This may require approximately 10% domestic and international travel. (This will not be the primary focus of this position)
Coordinate, schedule and participate in audit activities associated with GB's customers
Participate and assist in the activities associated with regulatory inspections of GB
Coordinate and participate in corporate audits
Support and facilitate the development, coordination and presentation of training programs within the areas of responsibility for the department and for others
Maintain current knowledge of regulatory and industry standards, trends and advancements
Perform walkthrough of all GxP areas (e.g. manufacturing, quality control, warehouse, facilities, and operations) to evaluate areas are in a state of compliance with applicable regulations
Follow up audit reports and related documents, assist with audit responses, verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions
This includes the issuance, tracking, review, and follow up of CAPAs relating to audits
Evaluate all GxP areas for its effectiveness in achieving the quality objectives established, as well as compliance with the applicable regulations
Support the preparation, performance, and responses, and CAPA management to corporate quality audits
Support supplier audits. May require approximately 10 % domestic and international travel
Follow up on reports and related documents verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions
Maintain professional and good working relationships with suppliers
Participate and assist in the activities associated with external inspections
Coordinate audit preparation and post audit activities
Track and follow up on corrective and preventive actions, near misses derived from external inspections, including CAPA tracking
Negotiate terms with suppliers
Coordinate with and obtain legal input
Track and follow up status
Draft and revise quality agreements
Evaluate quality agreement for its effectiveness in achieving quality objectives established, as well as compliance with the applicable regulations
Maintain the CAPA program for CAPAs related to audits
Follow up with responsible management to ensure timely and complete corrective actions
Hold CAPA meetings and present issues to management
Process change notification originating from sister companies
Issue notifications to applicable customers for internal changes
Issue and review supplier corrective action reports related to raw material issues
Follow up with suppliers
Evaluate the acceptability of supplier investigations and corrective actions
Follow established regulation, procedure, training, and due date
Qualification
Required
Bachelor's degree in one of the Life Sciences, Health Care or other Science or Engineering fields, or the equivalent of two years of industry experience is preferred
Industry experience within the Pharmaceutical, Biologics, Medical Device or Health Care Industry, which applies Quality Assurance or Quality Engineering practices. At least 5 years of experience in Regulatory Affairs, Compliance, Quality Engineering, Quality Control or Quality Assurance with emphasis on conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers
Working knowledge and understanding of concepts of GxP (e.g.cGMP and GLP). These practices should include other appropriate governmental and/or industry such as (ASQ, RAPS, CPA, ISO etc.)
Understanding of industry standard operational/manufacturing practices. Knowledge of US regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products. Familiar with ISO requirements
Good, verbal, written and negotiations skills
Computer literacy with proficiency in MS word, Access, and knowledge of Excel and PowerPoint
Able to work independently with minimal supervision
Well-developed communication skills especially in stand-up presentation or facilitation
Lead person qualities and interpersonal skills, being able to direct the work of others
Willing to adhere to Manufacturing and QC Laboratory gowning procedural requirements
Demonstrated leadership skills with the ability to motivate, guide, train, and coach department personnel. Ability to work independently with minimal supervision. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. Must be proactive, results oriented, and have strong attention to detail
Self-starter with strong work ethic and the ability to exercise good judgement. Ability to effectively prioritize and manage multiple tasks to meet targeted timeframes. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment
Must be flexible with working hours/shifts to accommodate the 24-hour, 7-day plant operation
Preferred
Specific experience with SAP preferred
Benefits
Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
Company data provided by crunchbase