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Quality Compliance Manager

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Want to take manufacturing to the next level? As Quality Compliance Manager you’ll ensures the Supply Quality Management System and associated activities are in compliance with current good manufacturing practice (cGMP) regulations, regulatory requirements and RB Global Healthcare standards.

 

Quality Compliance Manager

 Salt Lake City, UT

Competitive Salary & excellent benefits package

  • Medical, Dental, Vision and Prescription insurance – eligible on your 31st day of employment
  • Bonus Programs
  • 401(k) and Profit Sharing
  • 4 Weeks’ Vacation annually
  • Parental / Maternity Leave
  • Employee Assistance Program
  • On-Site Gym
  • On-Site Employee Store
  • And Much More!

Quality counts here. Responsible for one of our largest, most complex sites, you’ll ensure we meet the highest standards. Every time. You’ll build relationships to improve current practices and prevent mistakes. You’ll identify and create training needs, technical manuals and audits. You’ll work with colleagues and suppliers to ensure our brand reputation. You’ll ensure customers can continue to depend on us for product excellence.

 

You’ll succeed because…

…you’re committed to quality. You’ve a background in quality control or assurance, ideally in healthcare or a regulated manufacturing environment. You work best autonomously, taking ownership and initiative for your own results. You understand quality controls, technical manuals and process improvements. You’re diplomatic and tactful, meaning you can facilitate change and improve working practices and processes. You collaborate effectively and lead improvement.

 

You’ll love it because…

…you’ll have the freedom to make a difference. You’ll put your own ideas into practice. The products you help us get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Responsibilities

  • Ensures that the RB SLC Supply Quality Management System meets RB Global and regulatory standards (e.g. FDA, MHRA)
  • Manages Quality Compliance team to comply with Health, Safety & Environmental procedures and regulations
  • Coaches, mentors and trains Quality Compliance team
  • Monitors, reviews, and reports quality metrics and KPIs
  • Supports regulatory audits/inspections
  • Responsible for conducting Annual Product/Product Quality Reviews
  • Manages Supplier Qualification Program
  • Works with cross functional groups to ensure compliance, efficiency, competency and understanding, using accepted business best practice in a fast-moving health products environment
  • Ensures electronic systems and records and best practice technology remain fully compliant and continually improve effectiveness
  • Manages Complaint Handling process
  • To ensure documentation compliance and user friendliness within the environment
  • Responsible for TrackWise deviations, CAPAs, and Change Controls.
  • Manages and conducts internal and external quality audits

Qualifications

  • Minimum BS Degree in Life Science or Engineering
  • Minimum five years of Quality Assurance and/or Quality Compliance work experience in Pharmaceutical/Medical device industry
  • Minimum of three years managing a team in a Production/Quality function and have a good understanding of Quality Management Systems and RB pharmaceutical manufacturing and QC testing operations.
  • Able to manage and prioritize a busy workload to achieve deadlines and meet audit requirements
  • Comfortable in identifying non-compliance and failure risks to Supply Management on existing processes and operations and implementing robust change control processes to address this
  • A seasoned leader that will manage, coach and mentor the Quality Compliance team
  • Good understanding of pharmaceutical quality systems
  • Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH, and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry.
  • Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers
  • Experience using electronic quality management tools such as TrackWise and MasterControl preferred
  • Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem-solving teams, etc.
  • Must exhibit excellent communication and facilitation skills, both oral and written.
  • Analytically capable, able to understand and resolve technical issues
  • Project management skills are preferred

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Nearest Major Market: Salt Lake City

Job Segment: Medical, Medical Device, Healthcare

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