Regulatory Compliance, Manager

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary:

This position is a management level role and is responsible for overseeing internal cGxP audits, domestic and international supplier audits to ensure compliance in our practices and procedures.

This position will include the following major areas of responsibility:

Oversee and conduct internal cGxP audits.

Oversee and conduct domestic and international supplier audits

Manage and participate in customer, third party, and national or international regulatory agency audits

Manage Supplier Corrective Action Report (SCAR) system

Support raw material qualification program 

Oversee supplier management program 

Manage aufit CAPA system

Maintain the Site Master File

Manage quality agreements

Prepare reports and Key Performance Indicator summaries                                                                                                                                                                                                                                                                                                                                                                                                                                 

The Manager of Regulatory Compliance is responsible for the functions within the Regulatory Compliance department. These responsibilities include manage and participate in customer, third party, and national or international regulatory agency audits, draft and review quality agreements, partake in component/commodity qualification, supplier management, auditing, data analysis, etc. The incumbent is a management professional with high technical competency and leadership skills who directs the activities of the Regulatory Compliance department. The employee influences the direction of complex projects and communicates with all levels of employees including senior management.  The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others.  The employee is a fully qualified management professional who requires minimal supervision. Interactions by this position include collaboration within the GB site, other Grifols BioScience sites, suppliers/customers, and/or regulatory agencies.  As appropriate, this employee may serve as delegate to the department director.

ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.

● Manage the Regulatory Compliance operations and systems (cGxP regulatory, internal, and external audits including writing observation responses)                                                        

● Oversee supplier management system and supports the raw material qualification program                      

● Manage Audit CAPA system

● Maintain Site Master File                                                    

● Manage SCAR system                                                       

● Give guidance and support to production on cGMP compliance                                                  

● Manage Quality Agreement system                                                           

● Help develop annual budget expectations for Regulatory Compliance department

● Develop metric and benchmarking reports for presentation to top management. Proactively evaluate systems for trends and adverse findings. Identify, drive and implement improvements that result in sustainable compliance                                                      

● Provides support, direction and coaching to subordinate employees in the areas of the Regulatory Compliance department                                                        

● Communicates with cross functional departments and support groups to improve departmental performance and efficiency.                                                    

● Practices high level of facilitations skills to reach consensus and works toward solutions.                    

● Prepares and/or reviews/approves SOPs and other reports as needed   

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• B.S./B.A. in a scientific discipline with 8 years of experience in quality
• Regulatory Affairs Certification (RAC US/EU), Certified Quality Manager (CQM), or Certified Quality Auditor (CQA) certification a plus
• Typically requires a minimum of 3 years of related experience.  Supervisory experience preferred but not required.
• Minimum 3 years of Management experience

• Excellent communication skills (written and verbal)
• Thorough working knowledge of US FDA and European regulations
• Experience interacting with Regulatory Agency Investigations
• Fully competent in the use of Microsoft Word, Excel, and Access   
• Must lift 50 lbs            

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

The estimated pay scale for the Regulatory Compliance Manager role based in Los Angeles, CA, is $110,615 to $140,000 annual salary.  Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA 

Learn more about Grifols