Quality Manager - Distribution

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:

• 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.
• 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.
• Manages the monitoring of equipment requiring Validation and Requalifications.
• Maintains the Approved Supplier List for the Hospital Division
• Creates and updates procedures to ensure they are well established and reflect current practices.
• Performs Supplier surveillanceto ensure that the product being supplied to Grifols USA for distribution within the Unite States meets the US Regulatory Requirements
• 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.
• Ensures the distributors of the Bioscience products have an established and current quality agreement.
• Supports overall, other Grifols divisions (domestically & globally) in terms of achieving ISO certifications, to ensure a compliant Quality Management Systems, GDP, etc.
• 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.
• 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.

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.
• Proficient with FDA Requirements for biologics (CBER – Center for Biologics Evaluation and Research).
• Proven track record of performing and maintaining quality records that comply with regulatory requirements resulting in enhanced safety, profitability, productivity and quality.
• Strong organizational and project execution skills, with the ability to effectively manage multiple tasks, priorities and deadlines in a fast-paced environment.
• Proficient with Microsoft Office Suite; knowledge of project management applications.
• Excellent verbal and written communication skills.
• 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.
• Proficient with Good Distribution Practices.
• Strong leadership, mentoring and interpersonal skills with the ability to interact with personnel at all levels and work independently.
• Proficient with FDA Medical Device Requirements (CDRH – Center for Devices and Radiological Health).
• Must possess the personal characteristics or professionalism, commitment to excellence, customer service, detail orientation and accountability.
• Knowledgeable with USP 797 and USP 800
• Experience in working with multi-site manufacturing facilities for pharmaceutical or medical device companies (start-up, mid-size and high-volume manufacturing).
• 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.
• Proficient with ISO Standards (ISO 9001 – Quality Management Systems)

• 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.

The estimated pay scale for the Quality Manager - Distribution role based in Los Angeles, Cafifornia is $112,115.00-$140,000.00 per year/per hour. Additionally, the position is eligible to participate in up to 8% 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!

#LI-BK1

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

Learn more about Grifols