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Quality Assurance Sr. Supervisor

Your Role:

 

The Quality Assurance Sr. Supervisor is responsible for ensuring quality and regulatory compliance in accordance with customer requirements, company policies and domestic (US FDA) and International standards (ISO 9001, 13485).  Under direction of the Site Head of Quality, the Quality Assurance Sr. Supervisor works as a collaborative team member and leader to deliver site goals and objectives to drive business results and a continuous improvement culture.

 

  • Lead, manage and develop staff.  Hire, train and develop qualified staff to ensure effective execution of tasks, regulatory compliance, and attain operational and development goals.
  • Drive achievement of site vision and goals / objectives.
  • Manage implementation of quality management systems (QMS) in alignment with corporate standards.  Support ongoing quality system improvement programs and initiatives.
  • Drive improvement in customer experience – complaint reduction, supply reliability, field actions, audit performance, etc.
  • Coordinate the investigation and closure of deviations with specific emphasis on comprehensive root cause analysis. Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored.
  • Develop and implement standardized metrics that guide actions and promote continuous improvement.
  • Implement and maintain tracking and trending to identify potential out of trend conditions and proactively mitigate.
  • Review and approve documents such as SOPs, validation protocols and reports, deviation/CAPA plans, and change controls to ensure compliance.
  • Participate and/or lead internal and external audits.
  • Function as the Quality department liaison to other departments including but not limited to Quality Control, Product Release, Manufacturing Operations, New Product Development, Regulatory and Supplier quality.
  • Participate in FDA and ISO 9001 / ISO 13485 inspections as required.

 
Who You Are:


Basic Qualifications:

  • Bachelor’s Degree in a science related field, such as Chemistry, Biology, Pharmacy, Biomedical Engineering.
  • 3+ years of quality related experience within the life science industry.
  • 3+ years’ experience leading people/departments. 

 
Preferred Qualifications:

  • Strong command of quality systems supporting ISO 9001, ISO 13485, FDA regulations (such as 21CFR820, 21CFR 210 & 211).  MDSAP a strong plus.
  • Certifications: CQE, CQA, CMQ/OE, CQPA a plus
  • Proven strong leadership skills w/ ability to motivate, inspire, and build a high performing team.  Demonstrated ability to drive “followership”.
  • Strong written and verbal communication skills are a must.
  • Ability to manage in a complex, matrixed, and fast paced environment.  Able to triage workload effectively to drive departmental focus.
  • Requisite confidence and experience to drive effective, pragmatic and risk-based decisions.
  • High intellectual horsepower and proven problem-solving ability.  Good decision maker.
  • Collaborative and motivated team player.  Always looking to share and advance best practices.
  • Ability to drive change and challenge the status quo in a respectful/professional manner.
  • Experience leading a quality organization in a manufacturing setting – preferably managing in at least one of the following (Quality Ops, QC Labs, Quality Management Systems, Validation, Supplier Management) with proven track record of successful performance.
  • Experience working w/ customers and internal/external stakeholders.
Job Requisition ID:  192187
Location:  St. Louis
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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