- Build and establish the Regulatory department business strategyand plan. Set team objectives, key KPIs, prioritize, delegate, and monitor workto ensure the optimization of resources to deliver first-class service tocustomers both internally and externally.
- Hire,manage, motivate and coach direct reports to successfully fulfil their roles.Establish and maintain individual and department training plans to improveknowledge and skills and ensure business needs can be met as required.
- OverseeBSP product quality, regulatory and documentation requests for internal andexternal customers and act as a main point of contact for BSP suppliers andcustomers on escalated quality issues.
- OverseeBSP product and supplier approval processes and ongoing assessments, ensuringcompliance with regulatory requirements in all applicable regions.
- Bethe focal point for regulatory consulting experts, as required per country/market.
- Prepare, review and approve technical and quality agreements forBSP customers, aligned with BES sites capabilities.
- Communicate and ensureawareness of customer requirements throughout the Life Science team anddistribution site network.
- OverseeBSP product change notifications in line with BSP customer quality agreementsand Brenntag policies and procedures.
- SupportBSP customer and regulatory audits/inspections, as required.
- Carryout customer site visits to attend meetings as a quality representative ofBrenntag and to support commercial opportunities.
- SupportBrenntag distribution sites with implementation of certification schemes and registrationsfor distribution of BSP products.
- Compileand maintain a high level BSP Americas Life Science Overview FAQ and sitespecific information packs / SAQs on strategic cGMP Brenntag Americas sites.
- Collaboratewith other areas of the business to ensure that systems and procedures tosupport quality and regulatory compliance are developed, implemented,maintained, and supported.
- Identifytraining needs and develop training resources for the wider Brenntag group incollaboration with relevant departments.
- Compileand maintain an up-to-date system with regulatory information that is availablefor each region. Establish links with relevant regulatory authorities toreceive regulatory updates on new and proposed legislation that may impact thebusiness. Assess and communicate details on changes to the Pharma Services teamand distribution site network.
- Compileregular reports on department KPI performance, progress against objectives andother reports as required.
- Attendindustry trade shows as a quality representative of Brenntag and to supportcommercial opportunities.
- Holdor work towards membership of an appropriate professional body or industrygroup.
- Allother duties, as assigned.
- Degree in Microbiology,Biochemistry, Chemistry or suitable corresponding experience
- 10+ yearsof professional experience in Quality, Regulatory and Documentationwith demonstrated track record in solutions implementation with ability to leadand influence people through effective communication.
Director Regulatory Affairs and Value Added Services - Iselin, United States - Brenntag
Description
Stage Picture:
JobTitle:
Director Regulatory Affairs and Value Added Services
Location:
South Plainfield/USA
Employment Type:
Employee
Director Regulatory Affairs and Value Added Services
Our team in South Plainfield currently has an opening for a Director Regulatory Affairs and Value Added Services
YOUR ROLE & RESPONSIBILITIES
Job Summary:
Tolead and manage the strategic and operational performance of the Quality,Regulatory and Documentation Life Science, BSP Americas team, ensuringsuccessful delivery of the Life Science strategy, Key Performance Indicators(KPIs) and objectives.
Todrive compliance culture with cGMP and other applicable regulatory requirementsfor BSP products, and champion this across the wider Brenntag group. Contributeto the development of Life Science systems and processes that improve qualityassurance, product integrity and customer confidence.
To support the commercial team and contribute to the overallcommercial success of the Life Science team.
To manage all aspects around project pipelines on Value AddedServices.
Job Description:
Education and Experience:
INTERESTED?
We look forward receiving your application.
MariLynn Gross
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