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 Bioscience 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 Bioscience products have an established and current quality agreement.
• Tracks the shipping complaints associated with the distribution of Bioscience, Hospital and Clinical Diagnostic product 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, Inventory Control, review and closure of Hospital Call Center Service Cases.
• Manages the monitoring of equipment requiring Validation and Requalifications.
• Works with hospital 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. This includes the quality oversight of the company Warehouse in Doral, FL.
• Performs Supplier surveillanceto 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 for the Hospital Division
• Supports overall, other Grifols divisions (domestically & globally) in terms of achieving ISO certifications, to ensure a compliant Quality Management Systems, GDP, etc.

Job Requirements:

• Bachelor’s degree in life science or closely related field is required. Certification to a quality professional organization, e.g. ASQ CQA is highly preferred.
• 8 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 ISO Standards (ISO 9001 – Quality Management Systems)
• 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.

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  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.

EOE 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.

Pay scale of $112,115-140,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 8% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

Location: NORTH AMERICA : USA : CA-Los Angeles:US401 - LA CA-Headquarters

Learn more about Grifols