Sr. Manager, Global Quality Compliance
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.
This position will be responsible for ensuring that vendors supplying GxP materials and services to Emergent facilities are qualified to do so in accordance with Corporate and external regulatory expectations and requirements. The role encompasses all Supplier Quality Management (SQM)-related activities including vendor selection, audits, quality agreements and performance monitoring. Maintain and enhance quality management systems related to SQM, as well as working with external industry to identify and prepare for trends.
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 experience and good communication skills in both written and verbal format.
This position will report to the Senior Director, Global Quality Compliance.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Maintain and manage Emergent’s corporate external audit program:
o Ensure that the Approved Supplier list is maintained and up-to-date
o Develop a schedule of routine vendor audits and Emergent site audits and ensure that the audits are being conducted in accordance with the schedule
o Coordinate the conduct of vendor audits with Emergent’s auditor network, ensuring that the schedule reflects their participation and that of any subject matter experts.
• Serve as a corporate representative in discussions involving new vendors and assisting in the vendor selection process by conducting preliminary quality and compliance assessments
• Perform vendor audits as required
• Provide oversight and coordination around the execution of Quality Technical Agreements, Service Agreements, and other related contracts
• Oversee the coordination of change notifications and performance improvement plans for shared suppliers in a way that allows shared visibility at the site level.
• Develops, maintains, and communicates actionable performance metrics for key suppliers using feedback from Emergent’s manufacturing sites
• Provides support during regulatory inspections or customer audits as requested by the sites, before, during and/or after the event.
• Coordinates with Global Quality Compliance management to continuously improve the effectiveness, efficiency, and compliance of the Supplier Quality Management 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
• Lead the Global Supplier Quality Management Forum
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
• Bachelors of Science in Life Sciences or related degree.
• Minimum 10 years in GxP pharmaceutical environment in progressively responsible Quality roles.
• 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
• 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.
• Experience leading teams, preference of multiple countries
• Demonstrated past experiences in multiple quality roles
• 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
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.