Project Manager, Nucleic Acid Testing - IVD design control

Summary

The NAT Program Manager will be part of our Grifols Project Management Office (PMO) and is based in San Diego. The role will report directly into the Sr. Director NAT Project Management and work in the team of the NAT program for the fields of blood and plasma screening as well as Molecular Clinical Diagnostics. The Project Manager manages cross-functional teams while working with internal (including R&D, Manufacturing, Quality, Regulatory, Marketing, Technical Service and others) and external partners to achieve the business, operational and financial goals of the project/program, all the way through the lifecycle, from R&D to commercialization. The position oversees the creation of effective project strategies and the prioritization of initiatives and efforts. In parallel the individual will ensure that Grifols’ top priority projects get the appropriate visibility at management level. To be able to fulfil this role the individual should have experience in IVD product development / technical understanding of molecular biology as well as experience with IVD design control processes according to ISO 13485 and/ or 21CFR and/ or IVDD (IVDR). 7+ years of experience within the IVD industry and at least 3 years of experience as Project Manager or Project Leader is a must. Experience in working and coordinating complex projects requiring integration of all core disciplines and functional areas is a must.

Your primary responsibilities:

• Support a set of Core Teams and Program Steering Committees (PSC) essential to the cross-functional development of new or improved products at the NAT franchise.
• Monitoring of the life-cycle of existing products and the successful launching of new products.
• Support on the design and follow-up of the strategic KPIs for the Product Franchise to ensure a 360º view. Provide visibility on project status to leadership and stakeholders; Monitor program goals and accomplishments and raises problems/roadblocks when needed.
• Leading the relationship and be the main contact with certain partners for the franchise. You coordinate all the work with the different departments internally to ensure the common projects with the partners are executed appropriately. You follow up on every topic with the different internal and external stakeholders. This includes the management of meetings like Joint Development Committees and Joint Steering Committees, setting-up the agenda of topics, leading the discussion to achieve its resolution, preparing the minutes, etc.
• Support and work with heads of all Functional groups to ensure effective deployment of resources for the assigned project/s. Coordinate execution of projects affecting multiple areas; Prioritizes initiative and efforts; Monitors project/program budget and accomplishments.
• Establish and coordinate a portfolio management framework; Facilitate decision making around top priority projects; help on the estimation of high-level end-to-end costs; Ensure top priority projects have the appropriate visibility at management level to promote decision making and timely progress.

About you:

Knowledge, Skills, and Abilities we are looking for

• Technical skills to define need avoiding scope creep
• Cross functional skills (multiple areas involved)
• Business sense (understand value added of features vs cost to build them)
• Financial understanding to follow-up and monitor budgets and business cases
• Transparency & openness to quickly escalate issues or deviations
• Decision - making capacity/ Empowerment to avoid unexpected interruptions (bottle necks) in the schedule

Education and Experience we require for this role

• Bachelor’s degree, Master’s degree would be a plus. A scientific degree would be preferable (science, chemistry, biology, etc.).
• 7+ years of experience within the IVD industry, with at least 3 years of experience as Project Manager/Project Leader.
• Experience in managing project budgets; Must have experience in working and coordinating complex projects requiring integration of all core disciplines and functional areas and should include work with corporate partners.
• experience in design control processes according to ISO 13485 and/ or 21CFR and/ or IVDD (IVDR) preferred
• Ability to manage multiple cross-functional and cross-cultural project teams.
• Previous work experience in a multi-national organization.
• Ability to manage a partnership relationship with an external company, making strong ties with stakeholders.

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

PayScale

The estimated pay scale for the NAT Project Manager role based in San Diego, is $110,800 - $166,200 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, PPL, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

More benefits & perks

• Hybrid position, based in San Diego
• Paid vacation, paid holidays including two annual flex holidays
• Paid parental leave
• Professional development opportunities (training, career development)
• Gym pass program, employees’ perks program
• Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption benefits

Occupational Demands

Occasional travel will be required for this role; this is a cross-site and multi-company/partner program.  Role will be located in San Diego. Significant presence in the site will be required.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.