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Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Job Summary The Manager Global Clinical Quality (Clinical and Development Quality) is responsible for ensuring the Clinical (GCP) studies and pharmacovigilance / safety operations meet GXP and PV compliance requirements and supports and facilitates continuous improvement of those operations.
In addition, this role is responsible for supporting pharmacovigilance quality oversight activity for collaboration with core team members in Clinical (GCP), Regulatory Affairs (RA), and relevant Project/Program Management groups to ensure quality and compliance.
Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Serve as partner with the pharmacovigilance/safety team to ensure PV compliance 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 PV regulations and requirements, Acting as a strategic compliance resource providing support and guidance on the interpretation of 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 PV and Clinical procedures and processes to ensure compliance with regulations and industry standards QA support in inspection preparation and hosting PV related regulatory inspections, including pre-inspection and follow-up activities related to PV inspections.
Perform vendor qualification and re-qualification audits of PV/Safety related vendors as needed to support business needs and ensure compliance Review of medical assessments as needed to support clinical related investigations in support of IP Review of Aggregate Reports in support of Emergent Commercial and Clinical products as well as review of Emergent Regulatory filings, Information requests and related reports and technical documentation for compliance with regulations, guidance and industry standards Review and assess changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised processes Network across applicable Emergent sites/Functions/Teams and internal stakeholders to positively influence the compliance health of these operational areas and to drive quality decisions as part of the project team Working with Clinical and PV 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 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.
Education, Experience, & Skills Minimum Bachelor of Science (B.S.) degree Over 7 years of experience in the pharmaceutical industry, preferably in Clinical Quality Assurance and pharmacovigilance, in progressively responsible Quality or pharmacovigilance/safety roles 3-5 years leadership experience conducting and managing GCP quality assurance or pharmacovigilance 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, vaccines and/or devices Experience providing Quality Assurance, Clinical Operations or PV operational oversight in a minimum of two of the following disciplines (GLP, GVP, GCP) Strong interpersonal, verbal and written communication skills including technical writing 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 Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees.
This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
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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.