Senior Compliance Lead
Reckitt
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
The Sr. Compliance Lead provides quality compliance and technical support activities to the site. As a Quality leader, we are looking for a proven leader who can engage the team to not just deliver but identify and execute opportunities for improvement.
This is a leadership role which will ensure the Quality Management System and associated activities are in compliance with current good manufacturing practice (cGMP) regulations, regulatory requirements and RB Global Healthcare standards. To implement and oversee quality improvements in laboratory policies and procedures to meet company goals and GLP/GMP regulatory requirements.
A proactive role in working with Project Engineers, the Program Lead and the Technical team to provide Quality oversight of validation activity relating to computer systems, introduction of new equipment, and changes to current equipment.
Your responsibilities
- Ensure Quality Documentation (e.g. Standard Operating Procedures, Methods, Specifications, etc.) used within QC are correct and compliant to legislative requirements and adequately implemented to QC operations.
- Support the continuous development of QC operations and improving the approaches for transfer and implementation of new technologies.
- Quality contact for review and approvals of projects associated with computer systems and validation; while ensuring electronic systems and records and best practice technology remain fully compliant and continually improve effectiveness.
- Ensure compliant and effective delivery of Training systems, specifically for new technologies and methodologies users to ensure competency and adherence to QMS/Data Integrity requirements.
- Oversee the QMS and continuously develop and improve the monitoring systems for Compliance and ensure status is clearly identified by robust Key Performance Indicator (KPI).
- Works with cross functional groups to ensure compliance, efficiency, competency and understanding, using accepted business best practice in a fast-moving health products environment.
- Provide support to Regulatory Authority inspections and lead the delivery of corrective and preventive actions to non-compliances with specific reference to Regulatory Audit actions.
- Develop and champion Quality culture and creates a climate where people can do their best, seek out development opportunities and defines success in terms of a whole team. Valuing the safety of our associates and providing of a safe environment for the team.
The experience we're looking for
- BS in Science or Eng, 5 + yrs of QC exp in pharma/healthcare and 3+ yrs managing a team within QMS/QC testing operations.
- Familiar with lab processes/procedures and software application such as CDS; familiarity with LIMS, Empower, Chromeleon a +.
- Familiar with regulatory requirements GLP, GCP, GMP and documentation.
- Strong understanding of quality processes, knowledge of SAP QM modules, and exp with data entry/validation in SAP.
- CSA / Data Integrity requirements and programming (e.g. Visual Basic/VBA) is a +.
- Strong knowledge of applicable parts of Title 21 of the CFR, ICH, and significant leadership responsibility for quality systems development/maintenance in the pharma/health industry.
- Experience with SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma.
This role is not currently sponsoring visas or considering international movement at this time.