Quality Manager

1 month ago

Clayton, North Carolina, United States GRIFOLS, S.A. Full time


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.



Schedule: 1st Shift - 8:00 am to 5:00 pm

Location: Clayton, NC - Hybrid Model

Quality Manager - Documentation

The Quality Documentation Manager is responsible for managing the GT site Documentation Department and systems. This position Communicates with cross functional departments and support groups to improve compliance and efficiency of documentation workstreams. Collaborates and efficiently communicates to internal and external customers. Give guidance and support to production , quality control, and quality assurance on cGMP compliance as relates to documentation. Identify, drive, and implement improvements that result in sustainable compliance. Collaborates closely with GT department personnel as well as other Grifols' site SMEs in order to bring successful solutions to daily work challenges and successful implementation of projects. Practices high level of facilitations skills to reach consensus and work toward solutions. Participates in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.

Stays current on cGDocP guidances and regulations (including but not limited to cGMPs in US FDA CFR/USP, EP and Eudralex, and PIC/s) and implements these items systemically in GT's documentation. Ensures proactive compliance with quality metrics relative to GMP documentation (periodic reviews performed on or before time, status folders in the DMS are kept current without needing "clean up" events. Actively monitors and oversees weekly targets and facilitates collaboration with Quality and Manufacturing to meet closure metrics on docs, project support documentation, change control related documentation, etc... Responsible for the GT site's GMP documentation archives and contract with approved off-site storage services. Provides support, guidance, and direction to staff in order to achieve strategic business goals.

Translates vision into reality by deciphering corporate message and implementing strategy. Interprets business strategy and develops objectives to align and support the strategy. Works on issues of a diverse scope where analysis of the situation requires the evaluation of a variety of factors. Develops and administers schedules. Guides staff to achieve tactical and strategic business goals. Develops value added solutions that meet internal and/or external customer needs.

Must routinely demonstrate a continuous improvement approach to area of responsibility and have several examples of improvements implemented in previous positions. Lead and inspire others to seek improvement. Applies quality risk-based processes to seek continuous improvement of systems, processes, and facilities. Plans and analyzes workflow, delegation and prioritization, to ensure that assignments and projects are completed in a timely manner and within projected budget. Good organizational skills are a must and ability to routinely and independently follow up on items to completion such that implementation occurs on time or ahead of schedule. Ability to personally support business needs as high workload periods occur. Must have a demonstrated sense of steadiness and professionalism in stressful situations with focus on successful resolution. Uses expertise and sound judgment to make independent decisions within defined areas of responsibility. Strong analytical, organizational, and interpersonal skills required. Excellent written, verbal, and leadership skills required. Attention to detail and a proactive approach is a must.

Previous successful supervisory experience is preferred.

Education Requirements:

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

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 : NC-Clayton:USNC0002 - Clayton

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