Manager Quality Compliance

Manager Quality Compliance

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: Quality

Hours: Day Shift

Summary:

The Clayton Grifols Quality Compliance department provides leadership to support cGMP compliance of the large and dynamic multi-facility Clayton North Carolina campus. The North Carolina campus performs fractionation of blood plasma, purification, aseptic filling, lyophilization, final packaging, and warehousing of plasma related products. The Manager Quality Compliance will host external audits and will support and lead quality compliance and site initiatives for process improvement.

The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of personnel. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. Interactions by this position include collaboration within the GT Clayton site, other Grifols BioPharma sites, suppliers/customers, and/or regulatory agencies.

Primary Responsibilities for this Role:

• Manages all aspects of a Quality Compliance (quality systems, overall compliance, oversee department budget, employee relations, etc.).
• Follows cGMP and department safety practices.
• Provides guidance as well as consult with manufacturing, maintenance, logistics, 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.
• Host regulatory inspections/customer audits.
• Provide, oversee, and revise written responses to audit or inspection findings.
• Practices high level of facilitations skills to reach consensus and works toward solutions.
• Reviews and revises Standard Operating Procedures and generate reports.
• Initiates and manages corrective action plans for quality related issues.
• Collaborates and efficiently communicates to internal and external customers.
• Applies quality risk-based processes to seek continuous improvement of systems, processes, and facilities.
• Provides effective leadership to employees in the Quality department.
• Demonstrates high levels of value and integrity.

Additional Responsibilities:

• Review approve and manage quality agreements for suppliers, service providers, and customers.
• Review and approve change controls.
• Review, and/or approve validation and/or engineering documents.
• Participate in failure investigations.
• Author, edit, and/or publish SOPs and other documents.
• Lead, author, and review risk assessments.
• Perform, author, and review compliance gap assessments.
• Approve corrective action plans.
• Compiles and reviews departmental or site metrics.
• Provides guidance, leadership, and training for other employees.

Knowledge, Skills, and Abilities:

• Knowledge of domestic and foreign regulatory authority requirements.
• Investigation skills with nonconformances including root cause analysis and corrective/preventive actions.
• Excellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achieved.
• Demonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidance.
• Technical report writing skills with the ability to produce high quality documentation appropriate for the intended audience.
• Ability to think critically/strategically and act proactively.
• Demonstrates integrity and company values.
• Knowledge and experience using Microsoft Office applications.

Required Education:

• PHD in a Life Sciences, Chemical Sciences, or relevant STEM degree (science, technology, engineering, math, or computer science) with minimum of 6 years relevant experience.
• MS in a Life Sciences, Chemical Sciences, or relevant STEM degree (science, technology, engineering, math, or computer science) with minimum of 8 years relevant experience.
• BS in a Life Sciences, Chemical Sciences, or relevant STEM degree (science, technology, engineering, math, or computer science) with minimum of 10 years relevant experience.

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.