Manager Quality EM 524628
Manager Quality EM 524628
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Salary Not Disclosed
1 Vacancy
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 wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
Summary:
Responsible for managing all aspects (i.e. quality systems documentation laboratory operations compliance training staffing and budgetary needs etc. of the Quality Control (QC) Environmental Monitoring laboratory.
Primary responsibilities for role:
- Manages all aspects of a Quality Control business unit (quality systems documentation laboratory operations overall compliance oversee department budget employee relationsetc..
- Follows cGMP and department safety practices.
- Provides guidance as well as consults with manufacturing and internal regulatory departments on GXP matters.
- Uses expertise and sound judgment to make independent decisions within defined areas of responsibility.
- Plans and analyze work flow delegate and prioritize to ensure that assignments and projects are completed in a timely manner and within projected budget.
- Participates in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.
- May investigate and initiate corrective action places for quality related issues
- Demonstrates high levels of value and integrity.
Key Task List:
- Manage all asepcts (quality systems documentation operations compliance budget employee rleations) of the QC Environmental Assurance business unit which includes Environmental Assurance monitoring of facilities utility systems and fill lines.
- Authors and/or approves department SOPs performs investigations and write reports initiates and approves changes to department processes through change control management system and leads continuous improvement projects to improve EM methods and processes.
- Serves as system administrator for Environmental Assurance laboratory control systems such as SAP to ensure EM results and test data are available for site personnel as necessary to ensure timely reporting of test results to production business units to be used for product related decisions.
- Serves as SME regarding environmental monitoring issues and collaborates with production and QA projects incident investigations and annual product reviews.
- Participates for direct interaction with regulatory and internal inspections/audits including presenting site EM test and trending data answering EM related questions and providing written responses as necessary.
Requirements:
PHD in a Life Sciences or relevant degree with minimum of 6 years relevant experience or MS in a Life Sciences or relevant degree with minimum of 8 years relevant experience or BS in a Life Sciences or relevant degree with minimum of 10 years relevant experience
Experience in dealing with the FDA regarding license submissions inspections and audit followup required
Aeseptic/sterile filling experience preferred
*Depending on the area of assignment directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters degree with 2 years of experience
Benefits:
We offer a comprehensive package of benefits including medical Paid Time Off (PTO) annual bonus pharmacy dental vision disability insurance life & ADD insurance 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 familylike culture. Our company has more than tripled its workforce in the last 10 years were growing and you can grow with us!
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 68 hours per day. Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
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 : NCClayton:USNC0002 Clayton
Required Experience:
Manager
Employment Type
Full-Time
