Quality Manager

Kelly is actively recruiting for a Quality Manager as a Direct Hire in the Mountains of New Mexico. Must have Pharmaceutical or Cosmetic's background.

JOB SUMMARY: The Quality Manager works with quality management to develop, implement, and maintain the company Quality Management System which supports quality from product development through commercialization.

ESSENTIAL FUNCTIONS: This position assumes responsibility for the following duties:

  1. Work with Quality management team to develop a robust quality system, foster best practices and mentor and consult on Quality / Compliance issues across the organization. 
  2. Plans, establishes, and manages quality activities supporting GMP. 
  3. Provides management oversight for internal/external resources supporting GMP activities.
  4. Develops strong collaborative working relationships with key stakeholders, inside and outside the Company.
  5. Partner with cross functional team members to ensure personnel, process, documentation and quality standards meet expectations for regulatory submissions, regulatory authority inspection readiness, and compliance with applicable guidelines. 
  6. Revise and/or formulate quality and compliance policies in coordination with corporate management; ensure that all required systems and standard operating procedures are in place and current.
  7. Support change in the organization to continuously adapt to a dynamic business environment; apply learning to enhance organizational performance.
  8. Perform monitoring and audits of PLS operations and business environments to identify potential compliance risk areas; recommend and assist with the implementation of enhancements to existing policies and procedures and other corrective actions.
  9. Develop and maintain effective working relationships with stakeholder functions; foster an environment of collaboration, trust, quality, innovation and continuous improvement within the compliance organization and between other functional departments.
  10. Work with the Quality management team to identify and assess quality risks and ensure they are evaluated and managed appropriately in order to accomplish both business goals and regulatory and quality requirements.
  11. Ensure meaningful quality agreements with key services providers are established and followed.
  12. Identify emerging trends / changes and redesign processes and practices accordingly.

Minimum Requirements

Education: Minimum BA / BS or equivalent scientific degree is required. Advanced scientific degree is strongly preferred.

Experience:

  • A minimum of 5 years of Pharmaceutical industry experience in roles of increasing Quality Assurance, Quality Control, and Regulatory responsibility. 
  • Minimum 2 years directly related experience supporting compliance in a quality and compliance function.
  • Knowledge of QMS and CAPA related tools or systems is required.
  • Environmental monitoring and audit experience are required.

SKILLS/KNOWLEDGE/ABILITIES

  • Experience with health authority inspections and inspection readiness activities preferred.
  • Strong personal leadership with demonstrated competency interfacing with senior leaders is required
  • Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
  • Excellent communication skills.
  • Listening, interpreting and summarizing information.
  • Clear and concise verbal communication.
  • Professional and concise written communications – exceptional attention to detail.
  • Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
  • Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
  • Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
  • Strong project management skills: MS Word, Excel, PowerPoint.
  • Flexible and able to adapt to company growth and evolving responsibilities.
  • Excellent collaborative leadership style and coaching skills with ability to build and nurture strong, positive relationships with business leadership and cross functional partners.
  • Appreciation for all aspects of the pharmaceutical business, from research through sales and marketing, with the ability to operate cross-functionally and/or globally to achieve PLS goals.
  • Comprehensive knowledge of GMP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development, submission and commercialization.
  • Demonstrated ability to provide leadership for key strategic issues and significant quality policies, practices and processes.
  • Demonstrated ability to anticipate, proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards).

If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.

 

#TJP2021_SPEC



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]]
Company
Kelly
Posted
07/21/2021
Location
TAOS, NM 87571, US