Quality Manager (527241)
Quality Manager (527241)
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Job Description
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.
Note: This position is located in Research Triangle Park NC.
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.
- This role is hybrid and will work 3 days at the office and 2 remote.
- Travel requirement: 15%
Job Requirements:
- Bachelors 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 Standardsand 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.
Occupational Demands:
- Travel 15%
*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.
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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy childbirth or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location:NORTH AMERICA : USA : NC-RTP
NORTH AMERICA : USA : NC-Durham
NORTH AMERICA : USA : NC-North Carolina
NORTH AMERICA : USA : NC-Raleigh:USNC0001 - RTP NC-Headquarters
Required Experience:
Manager
Employment Type
Full-Time
