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Director, Global Quality- Data Integrity and Technology

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Nov 10, 2021

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details


 

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 

The Director, Global Quality- Data Integrity and Technology is responsible for ensuring compliance with applicable guidance and regulations for Emergent’s enterprise and multi-site systems including GXP, GAMP5, 21 CFR Part 11 (US) and EU Annex 11. These activities include Data Integrity program execution, advancing data integrity awareness, development and deployment of quality standards and procedures, oversight of computer system validation activities and leadership of continuous improvement efforts guiding software validation, data integrity, risk assessments, and lifecycle management. 
Lifecycle management activities include change and release management, deviation handling, and CAPA planning and execution. This position requires close cross-functional teamwork, an ability to understand and communicate risk, and a desire to coach and develop self and staff.    

Role reports directly to the Sr Director, Global QA IT and Data Integrity 

II: Responsibilites 
•    Execute Global QA commitments on strategic QA IT initiatives including Data Integrity and Data Governance
•    Collaborate with the IT organization to ensure adherence to Software Quality Lifecycle policies and procedures through project execution and periodic assessment activities.
•    Promote an organizational culture that encourages ethical conduct and adherence to fundamental principles of data integrity.
•    Drive data integrity assessments and remediation, in collaboration with Global Quality Leadership Team
•    Lead cross-functional teams to develop innovative solutions around data integrity 
•    Assess, manage, and communicate risk effectively, recognizing in general that risk is both proportional to complexity and inversely proportional to understanding. 
•    Partner effectively with internal and external customers to identify and implement improvements related to automation, project management, system development and change processes with the aim of building capacity.
•    Serve as a liaison between the Quality and IT organizations to identify future technologies that best support the business and its strategic objectives. 
•    Serve as a subject matter expert and provide quality assurance input on GxP-related IT projects, assessing user requirement specifications, validation scope and boundaries, and developing training materials and work instructions. 
•    Maintain staff by recruiting, selecting, orienting, training and developing employees and accomplish staff results by clearly communicating job expectations; planning, mentoring, coordinating; and enforcing systems, policies, procedures and productivity standards. 
•    Partner with the Director, Global Compliance to align Data Integrity principles and support periodic audits of global IT systems.
•    Work with Senior Quality leadership to ensure global policies reflect current regulatory requirements and best practices.
•    Participating as a member of project teams and approving validation documentation and change requests. 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills
•    Bachelor’s Degree in computer or life science (such as chemistry or biology)
•    Minimum of 10 years of pharmaceutical GXP Quality or IT experience with increasing responsibilities with a demonstrated proficiency in the application of IT solutions to GMP business processes 
•    Demonstrated managerial skill and experience 
•    Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500.
•    Practical experience with quality risk management and risk-based validation approaches
•    Excellent negotiating skills as well as verbal and written communication skills, especially for preparing project documentation
•    An established record of successful project completions employing proven engineering and project management skills
•    Strong experience of working in a collaborative team environment with other technical staff
•    Travel: 0-20% both domestic and/or international maybe required for aspects of the job (such as but not limited to: in person meetings, project support, training, audits, etc.)

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Company info
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States

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