Director, Global Quality- Data Integrity and Technology
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
• 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.)
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.
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.