Quality Assurance Systems Manager - BioScience
Company: Smithfield Foods
Location: Cincinnati
Posted on: May 9, 2024
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Job Description:
If you are currently employed at Smithfield, please log into
Workday and submit your application through the Jobs Hub.A great
job-and a great future-awaits you at Smithfield Foods. We're an $18
billion U.S. food company with nearly 60,000 employees worldwide.
We're looking for motivated people who want to join our team and
grow lasting and meaningful careers with us. Join our family today.
Apply Now!Your OpportunityOur team members receive
industry-competitive salaries and are eligible for great benefits
packages:--Competitive PayAnnual Bonus Earning
PotentialComprehensive Health Insurance, Retirement Benefits and
MoreEducation benefit available to full and part time Smithfield
team members on their first day of employment.Open to moving? We
will help! Ask about our Relocation Assistance packages!In
addition, we offer opportunities for career growth, professional
development, and tuition assistance.This is a full-time position
reporting to the Director Quality Assurance. As a Quality System
Manager in the pharmaceutical industry, your primary responsibility
will be to develop and maintain an effective quality management
system (QMS) to ensure compliance with pharmaceutical regulatory
requirements and industry standards. You will oversee quality
control processes, manage audits, and drive continuous improvement
initiatives to uphold product quality and safety. Additionally, you
will collaborate with cross-functional teams to support regulatory
submissions and maintain quality documentation.Core
Responsibilities----Develop, implement, and maintain a robust
quality management system aligned with relevant regulations and
standards for active pharmaceutical ingredient (API) manufacture
(e.g., 21 CFR 210/211, ICH Q7, FDA guidance documents).Establish
and monitor quality objectives, metrics, and key performance
indicators (KPIs) to evaluate the effectiveness of the QMS.Conduct
internal and external audits to assess compliance with regulatory
requirements and identify areas for improvement. Ensure timely
resolution of audit findings.Collaborate with research and
development, manufacturing, and regulatory affairs teams to ensure
quality considerations are integrated into product development and
manufacturing processes.Oversee the management of deviations,
non-conformities, and corrective and preventive actions (CAPAs) to
address quality issues and prevent recurrence.Implement and
maintain robust document control systems, including procedures,
work instructions, and quality records, ensuring their
accessibility and accuracy.Lead risk management activities,
including the identification, assessment, and mitigation of quality
risks throughout the product lifecycle.Develop and deliver quality
training programs to enhance employees' understanding of quality
requirements, standards, and processes.Monitor and analyze quality
data and trends to identify areas for improvement and drive
continuous quality improvement initiatives.Stay abreast of
regulatory changes, industry best practices, and technological
advancements in the field, and update the QMS accordingly.The above
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.QualificationsTo perform this job successfully,
an individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of
the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals to perform the
essential functions .----Bachelor's degree in a relevant scientific
or engineering discipline (e.g., biotechnology, life sciences,
chemical engineering) from an accredited four-year college or
university and 5+ plus years of relevant experience in quality
management in biotech or pharmaceutical industry.2+ years of
demonstrated experience in team management/development or project
leadership is requiredIn-depth knowledge of relevant regulations
and standards in the pharmaceutical industry (e.g., 21 CFR Part
210/211, ICH Q7, 21 CFR Part 11).Strong understanding of Good
Manufacturing Practices (GMP) and their application in the
pharmaceutical industry.Experience in developing, implementing, and
maintaining a quality management system.Experience in conducting
internal and external audits and managing audit programs.Proficient
with the TrackWise QMS modules for Quality Events, CAPA, OOS, and
Audit (or equivalent eQMS system).Familiarity with risk management
principles and tools, including FMEA (Failure Modes and Effects
Analysis) and risk assessment methodologies.Excellent analytical,
problem-solving, and root cause analysis skills, with the ability
to apply data-driven decision-making.Strong written and verbal
communication skills, with the ability to effectively interact with
cross-functional teams, regulatory authorities, and external
stakeholders.Relevant certifications such as Certified Quality
Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black
Belt are advantageous--EEO/AA InformationSmithfield is an equal
opportunity employer committed to workplace diversity. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
national origin, age, gender identity, protected veterans status,
status as a disabled individual or any other protected group status
or non-job characteristic as directed by law.If you are an
individual with a disability and would like to request a reasonable
accommodation for any part of the employment selection process,
please call us at 757-357-1595.Salary Range$85,500.00 -
$128,625.00--
Keywords: Smithfield Foods, Covington , Quality Assurance Systems Manager - BioScience, Executive , Cincinnati, Kentucky
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