Sr Manager, Global Quality Auditor
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
Sr. Manager, Global Auditing is responsible for the delivery and execution of the global Quality Assurance program audit activities on assigned GxP processes. This role is responsible for providing GxP oversight and for assuring the compliance of projects, products, and programs with Emergent Global Quality Standards, SOPs, policies, and all applicable regulations and guidelines.
This position is required to network across applicable Emergent sites and with internal stakeholders to positively influence the compliance health of these operational areas and will interact and influence project team decisions.
This position requires cross functional GXP knowledge, a willingness to learn, previous auditing (internal sites, Contract Manufactures, and Suppliers/Service providers) experience and good communication skills in both written and verbal format.
This position will report to the Senior Director, Global Quality Compliance.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Staying aware and up to date with agency regulations, guidance documents, and industry best practices, to ensure Emergent sites are held to current standards
• Leading and/or supporting Lessons Learned from audit findings to benefit other sites
• Execute audit strategy and lead process audits
• Establish and Lead an Audit Review Board to drive consistent approaches within audit reports
• Act as a reviewer of audit reports from internal or outsourced audits
• Lead and/or participate in auditor forums to help drive continuous improvement
• Monitor quality in support of maintaining inspection readiness
• Assist in developing and provide guidance for the implementation of fit-for-purpose and risk based GMP standards
• Develops, maintains, and communicates actionable performance metrics
• Provides support during regulatory inspections or customer audits as requested by the sites, before, during and/or after the event.
• Actively drive interactions with colleagues across the Emergent network to ensure consistency in application of transformation strategy and to promote standardization of auditing
• Coordinates with Global Quality Compliance management to continuously improve the effectiveness, efficiency, and compliance of the Internal Auditing program. Improvement activities include, but are not limited to, developing audit checklists, preparation of auditor training and certification materials, and implementation of policies and best practices
• Ability to support contract manufacturing/service provider/ supplier/ internal audits and site self-inspections as required
• Lead training/qualification program for internal auditors (global and site)
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 of Science in Life Sciences or related degree.
• Minimum 10 years in GxP pharmaceutical environment in progressively responsible Quality roles.
• 10+ years conducting audits
• Demonstrated experience of training and mentoring auditors on a global front
• Certified Auditor training with in one or multiple areas (ASQ, ISO 9001 and/or 13485)
• Demonstrated in depth understanding of GMP requirements for compliance with domestic and international regulations including those of the US FDA, Health Canada, and EMA in drugs, biologics and/or devices.
• Multi-disciplinary exposure to various GxP environments is required
• Displays critical thinking expertise, with the ability to define and implement a strategic approach to audit- based on compliance and business knowledge
• Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Is adept at interpreting GXP regulations in the resolution of problems and in the design of systems, processes or procedures.
• Ability to manage/lead global scale improvement plans
• Strong interpersonal, verbal and written communication skills
• Ability to work well in a fast-paced, team-oriented environment
• Excellent organizational ability – can easily multi-task and shift priorities as needed
• Attention to detail
• Ability to works independently with minimal supervision
• Ability to effectively plan, organize, and execute work that ensures deliverables are consistently met
• Nice to Haves:
o Demonstrated stakeholder and conflict management
o Demonstrated past experiences in multiple quality roles
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.