Sr. Specialist, Clinical Quality
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 (2-4 sentence description of overall job purpose)
The Specialist II, Global Clinical Quality (Development QA) is responsible for ensuring the Non-Clinical (GLP) and Clinical (GCP) studies and operations meet GXP compliance requirements and supports and facilitates continuous improvement of those operations. In addition this role is responsible for decision making regarding quality assurance topics and for collaboration with core team members in Clinical (GCP), Non-Clinical (GLP), Regulatory Affairs (RA), and relevant Project/Program Management groups to ensure quality and compliance with Clinical and Non-clinical quality systems. This is achieved through:
• Development, implementation, maintenance, and improvement of relevant Quality and operational systems,
• Serving as a core team member on development programs providing guidance on GCP and GLP regulations and requirements,
• Acting as a strategic compliance resource providing support and guidance on the interpretation of GCP and GLP regulations and industry best practices,
• Monitoring regulations for new and emerging trends and assessing for impact to Emergent’s operations,
• Providing Quality input on relevant Clinical and Non-Clinical documents,
• Leading, conducting and managing Clinical and Non-Clinical audit programs for internal processes and external vendors supporting these operations
This position is required to network across applicable Emergent sites/BUs and internal stakeholders to positively influence the compliance health of these operational areas and to drive quality decisions as part of the project team.
This position requires successful leadership and management skills, including excellent and timely communication and technical writing skills.
II: Responsibilites (Include key responsiblities only. This should not be an all encompassing list)
• Serve as strategic compliance resource in the interpretation and application of regulatory requirements for internal stakeholders in various GXP disciplines with a focus on Clinical (GCP) and Non-Clinical (GLP)
• QA Lead in inspection preparation and hosting regulatory inspections, including pre-inspection and follow-up activities related to GCP and GLP inspections.
• Review and assess changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised processes
• Working with Clinical and Non-Clinical groups, develop and maintain Standards for operations
• Lead Process improvement initiatives by working with Clinical and Non-Clinical groups to
• ensure processes/procedures meet organization and Quality requirements and standards
• Establish, monitor, track and report metrics which measure the health of the quality and operational systems
• Establish, monitor and track processes and metrics which measure the level of risk of studies, programs and sites
• Develop and manage internal audit schedule and conduct internal systems audits of Non-Clinical (GLP) and Clinical (GCP) systems, seeing audit observations through to completion
• Conduct external vendor qualification/re-qualification audits and develop and negotiate Quality Agreements with vendors performing GCP and GLP activities
• Support operations through the conduct of in-study audits (GLP or GCP)
• Manage and/or actively support for-cause activities
• Provide Quality oversight to all stages of Clinical and Non-clinical studies
• Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management
• Participate in integration or due diligence activities as required/requested
• Mentor and coach Global Clinical Quality Staff
• Development and delivery of GCP and GLP training
• Prepare and provide budget estimates to management, support budget updates, prepare Quality budgets as inputs to Requests for Proposals.
• Other duties as assigned.
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 of Science (B.S.) degree (preferably in Life Science)
• minimum of 7 years of experience in the Pharmaceutical industry preferably in Quality Assurance, in progressively responsible Quality roles
• 3-5 years experience conducting and managing GXP quality assurance audits
• Demonstrated understanding of GLP, GCP, and GVP requirements for compliance with domestic and international regulations including those of the US FDA, Health Canada, and EMA in biologics and/or devices
• Experience providing Quality Assurance or operational oversight in a minimum of two of the following disciplines (GLP, GVP, GCP)
• Strong interpersonal, verbal and written communication skills
• Must understand a variety of quality systems that support the product development lifecycle and post marketing arena
• Solid problem solving and critical thinking skills
• Previous experience in preparing for and hosting/responding to regulatory health authority inspections
• Ability to lead projects with minimal supervision required; to work independently and in a team-based environment
• Ability to effectively plan, organize, monitor, execute, and measure success of a project
• Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
• Demonstrated ability to develop and implement business processes and process improvements
• Travel: 25- 40% of time
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.