Quality Assurance & Regulatory Affairs Manager

Quicksilver Scientific Inc.'s picture
Job Description: 

Quicksilver is a pioneer in the natural health industry. Our mission is to deliver on the promise of natural medicine to optimize quality of life. Our growth is fueled by individuals who share our passion. Currently, we have an opening for a Quality Assurance & Regulatory Affairs Manager in our Louisville, CO location.

The Quality Assurance & Regulatory Affairs Manager is responsible for overseeing efforts by the Quality Assurance & Regulatory Affairs department which includes developing and administering quality systems processes throughout the organization. In concert with the leaders of the organization, the Quality Assurance and Regulatory Affairs Manager ensures compliance to all required regulations and laws. This position will manage the continuing review of quality processes and the formulation of new or revised procedures to affect improvements, reduce cost, and enhance efficiency on an organization-wide basis.

Core Responsibilities include:

Regulatory Affairs

  • Coordinate efforts associated with the preparation of regulatory documents or submissions, including establishment registration, product registration, and certificates to foreign governments. Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. Interpret regulatory laws or changes and ensure that they are communicated through corporate policies and procedures.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Lead cross-functional health claims adjustment process to establish risk profile for and ensure compliance of product, marketing, and general customer communication.
  • Prepare or maintain technical files and Food Safety Plans

Quality Assurance

  • Manage the document and records lifecycle process
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Lead and coordinate internal and external audits, 3rd party inspections, Corrective/Preventative Actions (CAPA), Deviations, post-market surveillance, supplier evaluation, contract review and recalls.
  • Project management of additions and upgrades to the Quality Management System.
  • Plan and execute multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
  • Assist the team in prioritizing, setting standards, and working collectively to accomplish goals, objectives and training requirements.
  • Possesses the ability to evaluate processes, identify efficiencies, and motivate change.

Qualifications:

  • Bachelor of Science degree in a scientific discipline or comparable field
  • 2+ years of Regulatory or QA experience in a regulated industry (i.e., pharmaceutical, medical device, food, dietary supplement) - including experience in a Lead role
  • CAPA and Internal Audit experience
  • cGMP experience
  • MS Office Suite-intermediate skill level
Ideal candidates have the following traits:
  • 5+ years of Regulatory or QA experience in a regulated industry (i.e., pharmaceutical, medical device, food, dietary supplement)
  • Strong interpersonal skills, written, and verbal, proven by effectively presenting information and responding to questions from coworkers, management, contractors, customers, etc.
  • Excellent leadership skills, including the ability to develop trust and credibility, lead by example, and motivate high-performing teams.
  • Model cGMP-adherent behavior and be willing to coach and train to encourage such behaviors in others.
  • Able to work in a team-oriented environment and follow StandardOperating Procedures.
  • Excellent oral and written communication skills.
  • Results driven, proactive, able to work autonomously, with the ability to relate to and work with a wide variety of stakeholders.
  • Self-starter able to take general direction, develop a detailed execution plan, and work independently.
  • Demonstrates Quicksilver Scientific's core values and behaviors.

Quicksilver offers a competitive benefits package including:

  • Employer paid Medical, Dental and Life insurance, including Short-term and Long-term Disability
  • 401(k) with company matching
  • Paid Time Off
  • Paid company holidays
  • Paid Parental Leave
  • Fitness Center membership
  • Generous employee discount program on all QS products

Location: Hybrid/Remote

Quicksilver Scientific is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

This job posting is in compliance with the Colorado "Equal Pay for Equal Work Act."

 

Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.

This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.