compliance officer Sandwich, England
Job description
Quality Oversight and Compliance Manager
Location – Sandwich, Walton Oaks, Remote
Salary – £23.39 - £28.58 Per Hour DOE
Have you got expertise in Regulatory Affairs, Regulatory Strategy and Submissions Management in the pharmaceutical industry?
We’re after a Quality Oversight and Compliance Manager who will be responsible for driving improvements to existing processes, supporting implementation and monitoring of initiatives related to pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Translation) information and processes globally through data reporting/ metrics analysis.
Responsibilities:
- You will identify opportunities for improvement of pan-regulatory data and business processes and procedures, through the collection and analysis of metric data in collaboration with Information Management, Analytics + Reporting, business process owners and other stakeholders.
- Provide accurate and detailed reports and presentations on the above activities for senior management, Quality councils and governance committees as required including executive summaries to Senior Management.
- Identify procedural/compliance gaps associated with in scope processes and establishes mitigation and remediation plans with business process owners that provide optimal balance of compliance and business need.
- Provide support to stakeholders in ensuring inspection readiness, preparing for audits/ inspections and provide remediation support for audit (or inspection) findings.
- Participate on cross functional teams to execute quality improvements.
- Leads/provides input to the investigation of suspected Quality Events (QEs), Corrective / Preventative Action (CAPA) plans and audits/inspections and owns resulting actions as appropriate.
- Generates metrics and data analysis in support of Quality Plans and other compliance initiatives.
Skills and Experience
- B.Sc., M.S. Ph.D. or equivalent in relevant subject.
- Proven project management aptitude and ability to quickly learn and use new systems, regulations and quality standards.
- Experience in leading investigations and managing CAPA plans.
- Strong knowledge of the drug development process, Regulatory Affairs, Regulatory Strategy and Submissions Management as well as Pharmaceutical company organisational structure, policies, and practices.
- Proven fluency with use of soft skills and ability to adapt core project management skills successfully within a dynamic line environment.
- Understanding of systems and electronic technologies used to support regulatory and submission process and planning activities and experience in process development and new technology implementation.
- Can translate data into information to support the business in taking action and decision making transforming ambiguous situations into structured outcomes
- Management of change in partnership with key stakeholders
- Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality driving highly complex projects to meet evolving business needs.
- Strong interpersonal skills with a demonstrated ability to work effectively in a matrix organisation.
- Strong analytical and organisational skills.
- Strong written and verbal communication skills.
About the Company
Our client is a well-known and respected medical and pharmaceutical manufacturer.
To find out more about the position, please apply and we will be in touch to discuss the role in more detail.
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Job Type: Full-time
Salary: £23.39-£28.58 per hour
Benefits:
- Company pension
Work Location: In person
Reference ID: MJCBD
