Director, Global Quality Systems Governance - Remote (Gaithersburg, MD, US, 2087

About the Role

The successful candidate will have a deep understanding of quality management systems, including GxP, and experience in implementing and maintaining these systems in a global organization. They will also have a strong track record of leadership and collaboration, with the ability to work effectively with cross-functional teams and stakeholders at all levels.

The role is based remotely, with the option to work from anywhere, making it an attractive option for those looking for a better work-life balance. Emergent BioSolutions is committed to protecting and saving lives, and this role will play a critical part in contributing to this mission.

What You Will Do

• Oversee and support global process owners for primary global quality management systems, including deviations, CAPA, Change Control, Training, and Document Control.
• Implement and deliver continuous improvement to the global quality management system, driving standardization and harmonization of practices across the network.
• Collaborate with other global process owners to ensure the 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.
• Develop and execute large-scale organizational change, including change management strategy and planning.
• Facilitate and coach teams to optimal solutions, with the ability to understand complex processes and problems.
• Implement global business processes and policies with a critical thinking approach and enterprise mindset.
• Manage and influence stakeholders across a broad spectrum of GxP topics, with excellent leadership, interpersonal, communication, negotiation, and problem-solving skills.
• Develop and maintain a culture of continuous improvement, with a focus on superior business performance.

What We Are Looking For

• Bachelor's Degree level in science, statistics, or math, with an advanced degree and/or MBA preferred.
• Minimum ten years of experience in the Biopharma/Pharmaceutical industry, with cross-functional experience and a strong understanding of quality management system philosophies.
• Excellent leadership, interpersonal, communication, negotiation, and problem-solving skills, with the ability to work effectively in a global, cross-cultural team.
• Sound understanding of regulated activities, health authority expectations, and GxP, with experience in implementing and maintaining quality management systems.
• Proven ability to understand complex processes and problems, with the ability to facilitate and coach teams to optimal solutions.
• Experience in developing and executing large-scale organizational change, including change management strategy and planning.
• Excellent written and oral communication abilities, with extensive experience with industry-standard software applications, including Microsoft Word, Excel, and PowerPoint.

Nice to Have

• Experience in a similar role, with a strong track record of leadership and collaboration.
• Knowledge of regulatory requirements and industry standards, including GxP and ISO 13485.
• Experience with quality management system software, such as TrackWise or EQMS.
• Certification in a quality-related field, such as Six Sigma or Lean.

Benefits and Perks

• Competitive salary, with a range of
  78,500 to $216,000 per year, depending on experience and qualifications.
• Comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and pension scheme.
• Opportunity to work remotely, with the flexibility to work from anywhere.
• Generous paid time off, including vacation days, sick leave, and holidays.
• Professional development opportunities, including training and education programs.
• Access to industry-standard software applications, including Microsoft Office and quality management system software.
• Collaborative and dynamic work environment, with a team of experienced professionals

• To stand out as a candidate, make sure to highlight your experience in quality management systems, including GxP, and your ability to drive continuous improvement and standardization of quality practices.
• Be prepared to provide specific examples of your leadership and collaboration skills, including experience working with cross-functional teams and stakeholders at all levels.
• Familiarize yourself with the company's products and services, as well as the current regulatory landscape, to demonstrate your knowledge and interest in the role.
• Use language from the job description in your resume and cover letter, to show that you have the skills and qualifications the company is looking for.
• Be prepared to discuss your experience with quality management system software, including TrackWise or EQMS, and your ability to implement and maintain these systems.
• Ask about the company culture and values during the interview, to show that you are interested in the company and the role, and to determine whether you would be a good fit.
• Be prepared to negotiate your salary, based on your experience and qualifications, and to discuss the benefits and perks of the role.