Manager, Quality Standards Development

PPTA seeks a Manager, Quality Standards Development to proactively advance, modernize, and operationalize the Association’s quality standards programs: International Quality Plasma Program (IQPP), and Quality Standards, Excellence and Leadership (QSEAL) Standards. This role is responsible for driving momentum and consensus in complex, multi‑stakeholder environments by identifying issues early, asking clarifying questions, proposing solutions, and ensuring steady progress from concept through implementation.

Reporting to the Senior Director, Global Plasma and International Affairs, and working in a matrix with internal teams, industry committees, and external vendors, the Manager serves as an execution‑oriented leader who balances consensus‑based standards development with the need for timely decision making, follow‑through, and results.

Core Responsibilities:

Standards Leadership & Development

• Drive the development, revision, and maintenance of industry standards by establishing timelines, advancing proposals, and ensuring follow‑through across committees and working groups.
• Proactively identify gaps, risks, or stalled decisions in standards development and propose paths forward for resolution.
• Prepare issue briefs, discussion frameworks, and draft language to support informed decision‑making by committees and leadership.
• Ensure standards documentation (including SOPs, program descriptions, and user manuals) remains current, accurate, and aligned with document retention and management policies.

Program Execution & Oversight

• Lead day‑to‑day execution of the International Quality Plasma Program (IQPP) and QSEAL Standards programs in collaboration with audit, regulatory, data, and administrative colleagues.
• Act as a primary point of coordination for audit issues and dispute resolution, ensuring timely escalation and closure.
• Partner with the audit manager on auditor recruitment, training, and quarterly auditor engagement.
• Collaborate with data management colleagues to ensure effective operation of data collection and reporting processes.

Vendor & Stakeholder Management

• Manage contracts and vendor relationships related to standards‑supporting systems, including the National Donor Deferral Registry (NDDR) and Cross Donation Check System (CDCS).
• Maintain active engagement with industry stakeholders, proactively surfacing questions, concerns, and opportunities for improvement.
• Represent the Association in standards‑related forums and working groups, as assigned.

Communications, Advocacy & Industry Engagement

• Collaborate with the Communications team to develop and implement materials that promote standards, certification programs, and source plasma collection.
• Draft articles, guidance documents, and explanatory materials for industry publications and member communications.
• Participate in advocacy activities on behalf of the industry, supporting the Association’s broader mission.

Qualifications:

• Bachelor’s degree required; background in life sciences preferred
• Advanced degree and/or quality certification a plus
• Plasma protein industry experience (manufacturing, quality, or regulatory), strongly preferred
• Minimum of 3 years’ experience in standards development, quality systems, program management, or a related field
• Experience working with associations or consensus‑based bodies strongly preferred
• Strong working knowledge of standards development processes
• Ability to operate effectively in matrixed and consensus‑driven environments while maintaining execution focus
• Demonstrated initiative, problem‑solving, and follow‑through
• Excellent listening, written and verbal communication skills
• Strong organizational skills with the ability to set priorities and manage multiple workstreams
• Willingness to travel as needed

Location: Washington, DC (near Union Station)

Salary range: $95k-110k – dependent upon individual qualifications

Anticipated start: June 2026

Benefits: Health, Vision, Dental, 401k, Life/Disability, Fitness, Public commuting/parking allowance, Hybrid work schedule, Performance bonus plan

How to Apply

Interested candidates are requested to submit their application by attachment to an e-mail to cizzi@pptaglobal.org, to the attention of Cathy Izzi.

About PPTA

The Plasma Protein Therapeutics Association (PPTA) is the global industry trade association representing the private sector collectors of source plasma (plasma for manufacturing) and manufacturers of plasma-derived therapies. As a trusted partner to health systems, PPTA drives broad and reliable access to plasma-derived medicinal products with a focus on the well-being of patients and plasma donors. These therapies are used by small patient populations worldwide to treat a variety of rare diseases and serious medical conditions.

About the PPTA Standards program

PPTA’s Voluntary Standards Program provides global leadership for the plasma protein industry’s goal of continuous improvement with a focus on safety and quality from the donor to the patient. The Standards program will be transparent, credible, innovative and responsive to stakeholder and industry needs.

PPTA has adopted Voluntary Standards and other criteria that apply to the collection and fractionation of plasma used for manufacturing plasma protein therapies. These standards are in addition to formal regulatory requirements and are intended to promote the safety and quality of plasma protein therapies. The International Quality Plasma Program (IQPP) provides an independent evaluation of adherence to global industry standards for source plasma, specifically focusing on donor management and health. The Quality Standards of Excellence, Assurance and Leadership (QSEAL) program addresses the manufacture of plasma protein therapies. Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

Working at PPTA

PPTA maintains a respectful culture and environment that fosters inclusivity, diversity, collaboration, equity, and innovation, and reflects the global communities we serve. We encourage every team member to contribute innovative solutions toward meeting our goals and objectives in support of our Mission. We respect the work-life balance necessary for the best performance of each team member to drive broad and reliable access to high-quality plasma protein therapies, with a focus on the well-being of patients and plasma donors.