Quality Systems and Standards Manager-- BioScience

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**** A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We’re looking for motivated people who want to join our team and grow lasting and meaningful careers with us.
** Apply Now!
**** THE VALUE YOU’LL BRING:
*** The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section.
*** Step Into a High-Impact Role in Quality Assurance!
**** a full-time role reporting to the Senior Quality Assurance Manager —
** a position that is important to our mission to deliver products that meet the highest global standards.

As a
** Quality Systems and Standards leader**, you’ll be on the front lines of
** enforcing current Good Manufacturing Practices (cGMP)
** and safeguarding the
** integrity of our quality management systems.
** You won’t just be checking boxes—you’ll be shaping the standards that ensure our FDA-registered facility operates with unmatched precision and compliance.

Your oversight will be critical to the
** manufacture of high-quality Active Pharmaceutical Ingredients (APIs) and medical device components,
** all in accordance with
** 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU regulatory guidelines**. You’ll own the Quality Management System, uphold process excellence, and be a key driver of continuous improvement and operational readiness.

If you're passionate about compliance, thrive in a fast-paced regulated environment, and are ready to lead with confidence—this is the opportunity for you.
*
* WHAT YOU’LL DO:

*** The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.
*** Quality Systems Leadership
*** The Quality Systems and Standards Manager (QSS) will be the Site Owner of the Quality Management System (QMS).
* The Manager will be responsible for Systems, Standard Operating Procedures and Tools to be in place and in use as well as being properly maintained.
* The Site QSS Manager is responsible for Continuous Improvement activities through participation in the Site Quality Council as well as administration of the Site Quality Road Map.
* Be a leading advocate of the Quality Culture within the QA Function as well as the Site.
Promote the values of a Learning Organization.
* Provide coaching/feedback to enhance the QA group and individuals’ professional performance and development
* Serving as a strategic partner, Champion a culture of quality-first thinking, driving Quality Excellence across departments.
** Quality Management System**
* ** QMS Maintenance:
** Maintain the Site Quality Management System (QMS) in a state of compliance with all applicable Regulations.
* ** QMS Governance**:
Administer Site QMS governance through management reviews to ensure its continuing suitability and effectiveness.
* ** Process Management:
** Develop and use effective monitoring and controls for key QMS processes. (ie: Deviations, Change Control; CAPAs)
* ** Metrics:
** Through Key Quality Performance Indicator (KPI) Dashboard, monitor Site quality systems performance.
* ** Data Integrity:
** Provide specific Site Wide data integrity (DI) awareness and training on an annual basis.
* ** Complaint Management:
** Responsible for the management of customer complaint handling process for the site.
* ** QMS Fit for

Purpose:

** Monitor Internal and External Factors Impacting the Quality Management System (i.e. emerging regulations, innovations that might impact the Site QMS). Stay current with evolving FDA, EU, and ICH regulations, ensuring company procedures remain aligned with global expectations.
** Quality Council / Quality Plan / Validation Master Plan**
* ** Quality Council Owner:
** Participate and manage the Site’s Quality Council as the process owner for Quality Planning and the QMS.
* ** Quality Council…