Quality Assurance Program Manager

Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our
core value of Passion for Quality through our more than 1300 hardworking 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 workan 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 handson nonsupervisory 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 thirdparty suppliers for meet the companys 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 USPs 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 crossfunctional 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 datadriven 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 systemwide 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 810 years of experience in the pharmaceutical/biopharmaceutical or chemical industry.
Bachelors 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 crossfunctional 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 multitask 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 factbased decisionmaking.
Additional Desired Preferences
Strong leadership capabilities in a dynamic business environment.
Highly motivated selfdirected 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 companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.

Compensation
Base Salary Range: USD $97000.00 $124750.00 annually.
Target Annual Bonus: Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other jobrelated 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.

Required Experience:

Manager