Sr. Manager/Manager Quality Operational Readiness (QOR)

GRIFOLS, S.A.•Valle Township, MO

23h

About The Position

The Global Quality Operational Readiness (QOR) Senior Manager/Manager drives 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 Senior Manager/Manager will lead cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations.

Requirements

Strategic Planning: The ability to assist in the development of long-term strategies to ensure continuous improvement and compliance with global quality standards
Leadership: Strong leadership skills to inspire and manage cross-functional teams across multiple regions
Analytical Thinking: Capability to analyze complex data and metrics to inform decision-making and identify areas for improvement
Communication: Exceptional communication skills to effectively convey quality standards and expectations to diverse stakeholders
Risk Management: Proficiency in identifying, assessing, and mitigating risks associated with product quality and compliance
Global Perspective: Understanding of international regulations, standards, and best practices in quality management
Problem-Solving: Ability to quickly identify issues and implement effective solutions to maintain quality standards
Adaptability: Flexibility to adapt to changing industry trends and regulatory requirements
Collaboration: Ability to work collaboratively with other departments and external partners to ensure quality across the entire process
Project Management: Skills to oversee multiple quality initiatives and projects simultaneously, ensuring timely and successful completion
Superior organizational capabilities: Demonstrated evidence of identifying issues and accelerating solutions, mitigations
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 5 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 7 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 9 years relevant experience.
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 6 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 8 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 10 years relevant experience.
There is a requirement for travel for this position. It is expected to have 15% to 50% travel to the other Biopharma sites in scope of support by Qualtiy Operational Readiness. Some of this travel will be international travel.

Responsibilities

Lead a team of SMEs to encourage collaboration and the exchange of best practices between quality teams at different sites. Focus will be on identifying and implementing best practices that are cGMP compliant, inspection-tested and successful, as well as efficient. These best practices will be contemporary with health authorities/regulatory agencies expectations.
Implement site-specific quality strategies, ensuring alignment with global policies and regulatory cGMP requirements (FDA, EMA, Health Canada, etc.).
Drive the implementation of Quality Management Systems (QMS), including documentation control, deviation management, CAPA, change control, release operations, training, and quality risk management.
Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments. Conduct practice sessions with key site personnel to have successful interactions with regualtory inspectors.
Develop and monitor project timelines, quality milestones, and risk mitigation plans for site readiness. Keep results (KPIs) visible to all stakeholders and to senior management on routine basis.
Use expertise and sound judgement to make independent decisions within defined area of responsibility. Apply biological product knowledge, ERP knowledge to the quality systems being implemented to ensure robust set up of quality systems.
As challenges arise during quality system implementation at new sites, the QOR Senior Manager/Manager will faciltiate and work with site Quality leads to problem solve, mitigate the risks, and improve processes. Strong grasp of quality risk-based processes and principles is a must.
Drive needed timelines and a sense of urgency with site Quality leads so that the overall project milestones are not adversely impacted by quality support. In all cases, ensure competent quality oversight is established in the new site processes.
Carry out visits to production plants to ensure compliance with regulations and quality standards. Perform walkthroughs in manufacturing, warehouse, other GMP areas to identify continuous improvement opportunities and partner with site management to get the improvements in place.
Model for teams the ability to proactively anticipate quality related solutions and robust quality systems (as will be needed for day to day effective operations or during review by external regulators). Emphasze proactive problem-solving rather than reactionary responses. Ensure quality systems are mapped accordingly.
Share expertise of product knowledge with site quality personnel to ensure continuity of appropriate quality oversight of product portfolios.