Specialist II, Global Quality Systems

Location
Gaithersburg, MD
Posted
Jul 29, 2021
Ref
771477400
Discipline
Quality, Quality Control
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Emergent BioSolutions Global Quality Systems Specialist II will serve as a program manager, managing the execution and deliverables associated with the harmonization of our Global Quality Management System across the enterprise.  More specifically, this Program Manager will lead/ assist in the development, design, and governance of our Global QMS by developing tools, processes and providing leadership across the matrix in order to maximize efficiency, effectiveness and compliance while enabling a culture of quality. This role may also facilitate groups of subject matter experts in process mapping, training sessions and provide leadership in developing organizational change management and communication plans. 

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality Systems 
•    Assist in the development and governance of our Global Quality Management System, including process harmonization, governance, management oversight.
•    Identify, prioritize, and oversee quality improvement efforts with a goal of continually improving efficiency, effectiveness, and compliance with applicable cGMP regulations. This may also include leading system / process engineering or redesign efforts, as required.
•    Participate in the development of global quality objectives (e.g., annual improvement priorities), ensuring that Quality Plan initiatives are properly planned, prioritized, resourced, executed and evaluated for effectiveness.
•    Provide leadership for global DEVIATION and CAPA issues, ensuring clear root causes are identified and addressed with robust, and where appropriate, global actions to prevent occurrence or reoccurrence of the event, and ensuring that actions are assessed for effectiveness post-implementation.
•    Define & maintain Roles and Responsibilities for Global QMS Governance, and the process and training needed to manage key roles across the Global & Site Quality Matrix.
•    Collaborate with Global Process Owners to build out the Quality System Architecture & Framework which includes the Process/Sub Process structure.
•    Lead and collaborate with Document control in the Development of a global document approval matrix.
•    Provide leadership in the Harmonization and development of Quality Management Oversight procedures, including but not limited to Quality Manual, Quality Policy. Management review etc..
•    Provide program management support for the execution of the Quality Systems 3 year roadmap
•    Lead and manage a Global Quality Systems Forum that connects QS leaders across the enterprise
•    Represent Quality Management Systems in the eQMS Governance Forum
•    Develop tools and templates to support the global organization in harmonizing the Quality Management System across the enterprise.
•    Develop standard tools and plans for Quality Management Systems Integrations
•    Facilitate process mapping sessions with stakeholders across the Quality System process elements
•    Own and Maintain Global QMS capacity model
•    Conduct stakeholder analysis and enterprise assessments to develop the organization change management plans
•    Develop and manage execution of communications plan
•    Lead and/or provide subject matter expertise in the development of role-based training content for owned process areas
•    Mentor, coach, challenge and develop project team members while serving as a role model of Emergent’s core values. 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree 
•    A minimum of eight (8) years of life sciences/cGMP experience; minimum of five years of life sciences/cGMP Quality experience.
•    Complex analysis of business impacts/scenarios, including risk management, financial analysis (e.g. ROI, Cost of Quality).
•    Strong communication skills: oral/written and listening
•    Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
•    Interpersonal skills: leadership, team building, consensus building, conflict resolution
•    Previous experience in Pharma, Biologics or Medical Device Quality Management Systems 
•    Must have good written and verbal communication skills with the ability to tailor communications to all levels in the organization and prepare appropriate updates to senior management and executive management.  
•    Proficiency in MS Office products or comparable word-processing, presentations and spreadsheet skills are required.
•    Experience in Organizational Change Management
 

 

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.