Sr. Manager, Global Quality Systems

Location
Gaithersburg, MD
Posted
Jul 09, 2021
Ref
761843600
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.

I.    JOB SUMMARY 

Emergent BioSolutions Global Quality Systems personnel lead/ assist in the development, design, and harmonization of the Global Quality Management System in order to maximize efficiency, effectiveness and compliance while enabling a culture of quality across the enterprise. This role will focus on harmonizing two Quality System foundational process areas; document control and training.  This role will lead a team of both direct and indirect subject matter experts in this harmonization effort.

II.    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 regular updates and KPI’s for Global Quality Management Review as reflected in the annual Global Quality Plan 
•    Provide oversight of the DEVIATION, CAPA and CHANGE CONTROL systems, 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.

Training 
•    Lead and/or provide subject matter expertise in the development of role-based training content for owned process areas
•    Ensure procedural alignment across the Training and Document Control processes
•    Ensure alignment and partnership between the training and document control teams
•    Participate and influence in the development and harmonization of the global training processes


Document Control 
•    Lead, develop, harmonize, and provide Global Process Ownership for the document control processes
•    Lead/Manage the document control team and the Global Document Control CoP (direct and indirect leadership)
•    Oversight of the document control function, ensuring procedures are effective, efficient and compliant and the training programs associated are engaging and effective for users
•    Partner with Quality IT in the development of an eDMS data architecture model that supports both Quality Systems and Manufacturing Execution system documentation needs
•    Ensure Emergent documentation retention requirements are applied to GXP documents and archived records are maintained and available for viewing.


Management
•    Define global support model, service levels and organizational design for Center of Excellence
•    All functions associated with recruitment and hiring process for EBSI Global Quality Systems positions.
•    Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
•    Conduct all aspects of the performance management cycle: personnel interviews, annual goal planning, performance reviews, development plans and ongoing mgmt. of personnel.
•    Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable. 
•    Mentor, coach, challenge and develop team members while serving as a role model of Emergent’s core values. 
•    Ensure the team effectively collaborates with key internal and external stakeholders, including manufacturing, regulatory affairs, engineering, development, supply chain and IT in accordance with our corporate values and practices such as Lean and Partners in Leadership. 
•    Plan and track all budgetary requirements.  Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel. Provide routine reports regarding budgetary updates and variances against approved budgets.

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. 

III. 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 management of quality systems and Quality department. Highly desirable to have minimum of 5 years of supervision experience. 
•    Must have personnel management skills and good written and verbal communication skills.  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 and spreadsheet skills are required.
•    Experience in organizational design and 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.