"Alerted.org

Senior Compliance Lead

City: Wilson

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

•Research & Development​

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

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._

The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Collaborator, R&D, Product Lifecycle Management.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.

We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

**Nearest Major Market:** Raleigh

**Nearest Secondary Market:** Rocky Mount

**Job Segment:** Counseling, Nutrition, Healthcare