Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our

core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity,

Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

This is a hands-on, non-supervisory position in Quality Assurance. This position works collaboratively across multiple departments to lead successful implementation of new operational strategies required to develop physical analytical materials. The incumbent is responsible for developing a Supplier Quality Management program for all third-party suppliers for meet the company’s quality, compliance and performance standards. This position will manage and monitor activities across established producers of USP material to ensure high quality materials and requirements are met. The incumbent will also be responsible for developing and implementing new business processes and solutions to support new business strategies, monitor performance, and measure organization effectiveness.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to highquality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with

the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Quality Assurance Program Manager has the following responsibilities:

• Leadership:

o Lead cross-functional teams to establish new business processes and systems required for development of USP physical materials with 3rd party suppliers.

• Supplier Quality Management Program:

o Develop, implement, and monitor the Supplier Quality Management program for custom products outsourced to 3rd party suppliers.

o Evaluate and approve new suppliers based on quality standards, certifications, and production capabilities.

o Conduct supplier audits/assessments to ensure compliance to organizations quality standards and operational expectations.

o Develop Quality Agreements to ensure compliance with quality standards and applicable regulatory requirements.

o Collect, trend, and analyze data to measure supplier performance, identify trends, and measure against quality metrics and Key Performance Indicators (KPI).

• Operational excellence:

o Develop and implement new business processes and solutions to support new business strategies, monitor performance, and measure organization effectiveness.

o Ensures continuous innovation to deliver leading edge and fit for purpose solutions to the organization.

o Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a monthly basis.

o Leverage Artificial Intelligence tools to make data-driven decisions, improve efficiencies, streamline processes, and optimize productivity.

• Project management:

o Oversee and execute projects from initiation to completion including planning, coordinating, and ensuring the successful delivery of projects within scope and timeline.

o Effectively communicate project updates and key decisions to stakeholders at all levels.

• ISO 9001/17025:

o Maintain a system-wide Quality Assurance Program for USP under ISO 9001, ISO

17025, ISO 17034, and other relevant global standards

• Perform other duties as required.

Who is USP Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:• Minimum of 8-10 years of experience in the pharmaceutical/biopharmaceutical or chemical industry.

• Bachelor’s degree in science area (Chemistry, Biology) and a combination of skills and experience in the pharmaceutical or related industry. • Minimum of 4 years of experience in supplier evaluation, auditing, and management.

• Thorough understanding of and experience with some aspect of quality and compliance, technical operations; interest and demonstrated ability to learn across several disciplines (manufacturing, quality, supply chain, technical development, regulatory, finance, operations,

etc.). Demonstrated experience in managing projects and setting up business processes.

• Demonstrated ability to effectively lead and influence cross-functional teams and suppliers not under direct organizational reporting lines to communicate challenging goals and achieve objectives.

• Must have successful experience with ISO 9001/17025/ 17034 and/or GMP.

• Strong computer skills. Experience developing and managing projects/programs including tools for milestones and resources.

• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.

• Demonstrated ability to accomplish results and meet deadlines and commitments.

• Strong interpersonal communications skills. Shares critical information with project team and senior leaders.

• Demonstrated analytical and logic skills with a focus on fact-based decision-making.

Additional Desired Preferences

• Strong leadership capabilities in a dynamic business environment.

• Highly motivated, self-directed, and have the ability to work independently while handling multiple tasks.

• Demonstrated ability to build strong, credible working relationships across the organization and to communicate and interface with customers, third parties, and diverse audiences at all levels of the organization.

• Ability to structure an issue and analyze alternative and creative solutions using metrics, good analytical skills, risk level, and other data and methods to evaluate data and trends for lessons learned, required action, etc.

• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints. Proven ability to raise and resolve issues when others are directly accountable for outcomes.

• Certified Quality Auditor

Supervisory Responsibilities

None, this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Compensation

Base Salary Range: USD $97,000.00 – $124,750.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Quality Assurance

Job Type Full-Time