Director, Global Quality Standards - Military Veterans

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

The Director, of Quality Standards leads the Quality and Strategic Activities in the Reference Standard and Documentary Standard Setting process at USP. This position provides global leadership and innovative management of the organization’s quality system through the development, implementation, and monitoring of Quality programs, policies, and procedures.

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 high quality, 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 Director, Global Quality Standards has the following responsibilities:

• Leadership : Lead a team that fosters a culture of continuous improvement and innovation; collaborates and/or leads cross-functionally with business partners to meet organizational goals to advance the reach of USP initiatives and to ensure quality function is integrated throughout the USP products lifecycle



• Reference Standards/Documentary Standards:

o Establish quality policies/procedures for the development of new and existing Reference Standards and Documentary Standards.

o Stay current with technology that benefits the development of Reference Standards and Documentary Standards publications.

o Develop, implement, and monitor compendial and reference standard quality-related activities.

o Proactively identify areas of risk and work with business partners to create solutions that minimize risks.

• Digital Products/Data Quality:

o Collaborate and provide a quality assessment based on customer perspective and applicable regulatory requirements for continued development of Digital Publications (USP-NF, FCC, DSC, PF, FCC Forum, etc)

o Stay updated on Data Governance and Data Quality

o Participate and provide input based on quality findings strategies to improve data quality.

o Contribute on data quality thresholds/rules, assessment, resolutions, monitoring, and control.

• Quality Systems:

o Develop, implement, and monitor Quality programs, policies, procedures to ensure compliance with certifications/accreditations and corporate policies.

o Lead teams for complex projects/initiatives across multiple functions and global sites.

o Manage quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions.

o Identify, assess, and develop mitigation strategies to quality-related risks through a robust risk management program.

o Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies.

o Identify and implement quality control gates for digital processes, automation, and case management.

• Quality KPIs/Metrics:

o Establish and monitor enterprise-wide and program/project-specific KPIs/Metrics.

o Formulate strategies for continuous improvement as well as opportunities for efficiencies and productivity gains.

• ISO 9001/17025/17034 : Maintain a system-wide Quality Assurance Program for USP under ISO 9001, ISO 17025, ISO 17034, and other relevant global standards.



• T alent Development : Recruit, retain, and develop a collaborative and high-performance global team by creating a diverse and inclusive environment. Create cross-training opportunities for staff to improve and/or develop new strengths.

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:

• Bachelor of Science with a minimum of 10 years’ experience in a pharmaceutical, biotech , or other regulated industry developing/implementing a Quality Management System. Minimum 5 years of supervisory/management experience.



• Proven experience in leading quality assurance teams and managing complex quality initiatives.



• Successful experience with ISO 9001/ISO 17025 and/or GMP including maintaining certification levels both domestically and internationally.



• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.



• Proficiency in data analysis and reporting tools.



• Strong written, verbal, and presentation skills with the ability to communicate effectively across different organizational levels.



• Strong analytical and problem-solving skills.



• Proficient in conflict negotiation and resolution; ability to influence across disciplines and at all levels.

Additional Desired Preferences

• Strong leadership capabilities in managing a high performing quality team with an aptitude of managing and prioritizing multiple projects and initiatives.



• Strong interpersonal skills with the ability to collaborate and build relationships with diverse internal/external business partners.



• Demonstrated ability to identify areas of potential quality non-conformance, successfully apply process acumen to resolve operational issues, identify gaps, and assure conformance.



• Solid independent and creative thinking ability to discern multiple viewpoints.

Supervisory Responsibilities

Yes:

• 1 Quality Assurance Manager



• 1 Senior Quality Assurance Specialist



• 4 Quality Assurance Specialist III



• 2 Quality Assurance Specialist II

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 $157,500.00 - $209,500.00 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