Director, Global Quality Systems Governance
Gaithersburg, MD, US, 20879 US
Preparedness today, safer tomorrow.
Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed
by our values and commitment to protecting and saving lives.
Job Summary
The Director, Global Quality Management Systems is responsible for the delivery and execution of the Global Quality Management Systems in support of the overall quality Strategy. This role is responsible for providing technical input into the implementation and helping to drive continuous improvement of the GxP Quality management Systems to ensure they are contemporaneous and right sized for the organizational needs. This role will report directly to the VP Quality, Enterprise GxP Compliance and Systems.
Essential Functions
- Overseeing and supporting the global process owners for the primary global quality management systems including deviations, CAPA, Change Control, Training, Document Control.
- Implementing and delivering continuous improvement to the global quality management system.
- Driving change management across the network to achieve standardization / harmonization of practices across the network.
- Collaboration with Other global process owners to ensure overall quality system remains contemporaneous and fit for use for the network.
- Lead cross functional teams to ensure continuous improvement of the governing QMS framework processes and related technologies.
- Hire, develop, and retain quality personnel to create a high-performing capable team.
Minimum Education, Experience, Skills
- Bachelor’s Degree level in science, statistics, or math. Advanced degree and/or MBA a preferred.
- Minimum ten (10) years of experience in the Biopharma/Pharmaceutical industry with cross-functional experience.
- Should have an excellent understanding of Quality Management System philosophies.
- Excellent leadership, interpersonal, communication, negotiation, and problem-solving skills.
- Sound understanding of regulated activities, health authority expectations, and GxP.
- Excellent organizational awareness, including significant experience working cross-functionally and in global, cross-cultural teams.
- Experience developing and executing large-scale organizational change, including change management strategy and planning.
- Proven ability to understand complex processes/problems and facilitate/coach teams to optimal solutions.
- Ability to implement global business processes/policies with a critical thinking approach and enterprise mindset.
- Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.
- Experience in leadership and support of an organizational culture that promotes and sustains quality as an element of superior business performance.
- Excellent written and oral communication abilities.
- Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint).
- Ability to effectively maintain a culture of continuous improvement is essential.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $178,500 - $216,000. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Nearest Major Market: Washington DC