Sr. Quality Systems Specialist, Quality Operational Readiness (QOR)

GRIFOLS, S.A.

14d

About The Position

The Global Quality Operational Readiness (QOR) Sr. Quality Systems Specialist supports the implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities (as well as new processes/faciltities at existing sites) across the EU, US, Canada, and other global locations. This role is instrumental in ensuring new sites meet global regulatory requirements and internal quality standards from the inception. The Global Quality QOR Sr. Quality Systems Specialist will work in the framework of cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Grifols BioPharma site's Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations.

Requirements

PhD in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 4 years relevant experience.
MS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 6 years relevant experience.
BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 7 years relevant experience OR an equivilant combination of education and experience.

Responsibilities

Facilitate the transfer of knowledge and best practices from other established Grifols sites (Technology Transfer process).
Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory Affairs, IT) to ensure quality is embedded in all aspects of site design and operations for new start up process.
Monitor project timelines, quality milestones, and risk mitigation plans for site readiness.
Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments.
Assist new start up site with review of validation master plans, sampling plans, master data setup, site master file development, product and raw material specifications, etc…
Use expertise and sound judgement to make recommendations to site Quality and Global Quality regarding improvement opportunities.
Assist BioPharma sites with recommendations for problem solving, mitigation of identified quality risks, and improvement of processes.
Monitor needed timelines and a sense of urgency with site Quality contacts so that the overall project milestones are not adversely impacted by quality support.
Carry out visits to production plants to ensure compliance with regulations and quality standards.
Proactively identify quality related solutions and robust quality systems (as will be needed for day to day effective operations or during review by external regulators).
This position will work with individuals and teams of SMEs from within QOR and at the BioPharma sites to drive and monitor continous improvement and operational preparedness activities.