R&D QA & Audit Specialist

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.

We are seeking a dedicated professional to join our SIO Plasma R&D QA team. In this role, you will oversee quality tasks and audits assigned to the group, ensuring compliance with GxP regulations, Grifols' Global Quality System, and specifically the R&D Quality System. Your main responsibilities will include reviewing documentation (procedures, protocols, reports, and primary data), conducting internal audits, qualifying vendors, and monitoring the R&D quality system (deviations, CAPAs, and more). Additionally, you will interact with various SIO Plasma R&D groups to resolve QA-related queries and plan strategies. You will also manage and maintain the R&D Quality System at a technical level.

Main Responsibilities:

Supervision of Documentation Generated by Pre-Clinical SIO Groups

1. Review of primary data related to studies, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GMP, GLP).
2. Review and approval of study protocols and reports, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP).
3. Review and approval of procedures, following internal procedures and applicable regulations/guidelines, if necessary (GCLP, GLP).

Audits

1. Participation in the planning of the R&D QA Annual Audit Plan to define internal audits for various SIO Pre-Clinical groups, based on procedures, risk analysis, and new studies.
2. Conducting scheduled internal audits for SIO Pre-Clinical groups, which may include facilities or studies.
3. Conducting audits requested by other groups external to SIO Pre-Clinical, within the expertise area of R&D QA.

Vendor Qualification

1. Conducting the qualification and re-qualification process for vendors used by SIO Pre-Clinical groups.
2. Conducting qualification and re-qualification audits for vendors, as deemed necessary.
3. Conducting qualification and re-qualification audits requested by other Grifols Quality groups, within the expertise area of R&D QA.

R&D Quality System

1. Review and approval of deviations from groups generated under the supervision of R&D QA.
2. Management, review, and approval of CAPAs from groups generated under the supervision of R&D QA.
3. Monitoring KPIs related to Quality Management of groups under the supervision of R&D QA. Compilation and drafting of the R&D Quality Annual Report.
4. Participation in adapting the R&D Quality System to new situations that may arise. Drafting and reviewing procedures.
5. Acting as a Quality expert within multidisciplinary teams for new Grifols projects.
6. Managing and collaborating with IT in the technical maintenance of the R&D Quality System.
7. Communication with different groups located worldwide.

Knowledge, Skills, and Abilities:

Strong integrity and commitment to quality and compliance, with the ability to understand pharma-related regulations and proficiency with computers. Ability to work flexible schedules to meet business needs, demonstrating good organizational skills and attention to detail. A high capacity for teamwork is required to work daily with different groups, developing strong interpersonal communication, organizational, and problem-solving skills. Additionally, analytical, evaluative, and sometimes conflict resolution skills are necessary.

Education:

Life Sciences Degree.

Experience:

A minimum of 2 years, preferably 5, in a similar role or relevant experience in Quality.

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.