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.

Job Overview:

The Quality Manager will provide support to the Technical Director to ensure compliance of Quality Operations, Regulatory and cGMP Compliance Program of Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/FDA/EN ISO Quality standards, Good Distribution Practices and Internal Quality Standard Operating Procedures) within the organization. The position ensures that the quality systems are in compliance with the rules and regulations of the regulatory agencies (FDA 21CFR, PIC/s GDP & EN ISO 9001) and that the company policies and procedures are being followed.

Essential Job Duties:

• Manages the customers of the distributed medicinal products to ensure compliance to Good Distribution Practices. This includes qualification and requalification via risk analysis, desk audit or on-site audit.

• Ensures the distributors of the medicinal products and medical devices have an established and current quality agreement.

• Tracks the shipping complaints associated with the distribution of the products to ensure they are appropriately reported, recorded and resolved on a timely basis.

• Creates and updates procedures to ensure they are well established and reflect current practices.

• Serves as the Training Coordinator (GTP and Manual Training) to establish the Training Profiles of new employees and distribute and manage the training responsibilities that must be processed manually for affiliate personnel.

• Responsible for the review and record keeping of Quality Systems records: CAPA, NCR, Complaints, Returns, Manages the monitoring of equipment requiring Validation and Requalifications.

• Works with Customer Service to ensure supplier/product/materials are reviewed for Regulatory Requirements by Global Marketing and approved by for distribution within the United States prior to issuing an SAP Code.

• Performs Internal Audits to ensure that the Quality Systems are compliant to Good Distribution Practices and ISO 9001 Standards. Performs Supplier surveillance to ensure that the product being supplied to Grifols USA for distribution within the Unite States meets the US Regulatory Requirements

• Maintains the Approved Supplier List Supports overall, other Grifols divisions (domestically & globally) to ensure a compliant Quality Management Systems, GDP, etc.

Job Requirements:

• Bachelor’s degree in life science or closely related field is required. Nice to have a Certification to a quality professional organization, e.g. ASQ CQA.

• 5 years of extensive quality assurance/quality compliance experience working in a domestic and global manufacturing matrixed environment within a pharmaceutical, medical device, GMP or FDA regulated industry.

• Must be able to demonstrate a deep knowledge of pharmaceutical, biotech, or medical device Quality Assurance/Quality Systems and theory.

• Comprehensive knowledge and understanding of cGMPs, FDA regulations, ISO 9001 Standards and industry guidelines.

• Proven track record of performing and maintaining quality records that comply with regulatory requirements resulting in enhanced safety, profitability, productivity and quality.

• Experience in working with multi-site manufacturing facilities for pharmaceutical or medical device companies (start-up, mid-size and high-volume manufacturing).

• Proficient with Good Distribution Practices.

• Proficient with FDA Medical Device Requirements (CDRH – Center for Devices and Radiological Health).

• Proficient with FDA Requirements for biologics (CBER – Center for Biologics Evaluation and Research).

• Knowledgeable with USP 797 and USP 800

• Strong leadership, mentoring and interpersonal skills with the ability to interact with personnel at all levels and work independently.

• Strong organizational and project execution skills, with the ability to effectively manage multiple tasks, priorities and deadlines in a fast-paced environment.

• Must possess the personal characteristics or professionalism, commitment to excellence, customer service, detail orientation and accountability.

• Excellent verbal and written communication skills.

• Proficient with Microsoft Office Suite; knowledge of project management applications.

This role is hybrid and will work 3 days at the office and 2 remote.

The estimated pay scale for the Quality Manager role based in Los Angeles, California is $120,000 to $150,000 per year. 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!

*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned, and qualifications required may change.

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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.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 527241

Type: Regular Full-Time

Job Category: Quality