Senior Quality Manager

1 week ago

Lompoc, California, United States DenMat Holdings, LLC Full time
Job Overview

Position Summary

In this role, you will be responsible for establishing and executing departmental goals and strategies to align with the overarching objectives of the organization.

Key Responsibilities include, but are not limited to:

  1. Oversee and manage the functions of Quality Control and Quality Assurance to meet company targets and resolve operational challenges; collaborate with various departments to achieve these goals.
  2. Ensure compliance with relevant regulations including cGMP, ISO13485, and 21 CFR 211 and 820, pertaining to the production and distribution of pharmaceuticals, medical devices, and cosmetics.
  3. Supervise quality control processes through subordinate staff, ensuring adherence to product specifications and quality standards.
  4. Direct Quality Engineering initiatives related to the design, execution, and enhancement of complex manufacturing processes to boost quality and efficiency.
  5. Conduct Management Reviews and Annual Product Reviews in line with the Company’s Quality Management framework.
  6. Identify and propose technical enhancements and projects for management consideration.
  7. Assist in the development of specifications and drawings for existing products and materials.
  8. Support the qualification of new or modified raw materials, suppliers, and processes.
  9. Act as the designated Management Representative for the Company, representing in discussions with regulatory bodies and agencies.
  10. Monitor regulatory changes across key markets including the U.S. and E.U.
  11. Support Lean, 5S, and Six Sigma initiatives related to manufacturing.
  12. Facilitate the transition of new product processes from R&D to production, including prototype development and testing.
  13. Ensure comprehensive documentation for all drug products, including Master Production Records and Batch Production Records.
  14. Coordinate with vendors and suppliers for the procurement of necessary equipment and materials.
  15. Provide technical support for regulatory submissions, including US 510(k) and EU Technical File documentation.
  16. Lead investigations into product failures and root cause analysis.
  17. Manage projects, including planning, budgeting, and scheduling to ensure timely and cost-effective completion.
  18. Delegate tasks to technical staff and monitor project performance.
  19. Evaluate and enhance departmental procedures and practices.
  20. Analyze departmental costs and implement cost-saving measures.
  21. Oversee personnel actions including hiring, promotions, and disciplinary measures.
  22. Conduct employee evaluations and identify training needs.
  23. Exhibit high standards of professionalism and work ethics.
  24. Represent the company positively in all interactions.

Additional Responsibilities may include:

  1. Providing technical support to Sales, Customer Service, and other departments as needed.
  2. Traveling for business purposes as required.
  3. Performing other related tasks as assigned.

Supervisory Duties

Manage supervisory responsibilities in accordance with organizational policies, including hiring, training, and performance appraisal.

Qualifications

A Bachelor’s degree in Engineering or a related field, coupled with 5-8 years of experience in operational, manufacturing, or quality assurance roles within the drug manufacturing sector. A minimum of five years in the drug manufacturing industry is essential.

Skills and Abilities

To succeed in this position, candidates must demonstrate:

  • Strong analytical and problem-solving skills.
  • Proficiency in reading and interpreting technical documents and regulations.
  • Effective communication skills, both written and verbal.
  • Ability to manage multiple projects in a fast-paced environment.
  • Knowledge of international drug and device regulations.
  • Leadership capabilities and the ability to work collaboratively with diverse teams.

Physical Requirements

Must be able to perform the essential functions of the job, which may include sitting, standing, and lifting up to 25 pounds. Personal protective equipment may be required in certain environments.

Compensation and Benefits

The salary range for this position is competitive and commensurate with experience, along with a comprehensive benefits package.

DenMat Holdings, LLC is an Equal Opportunity Employer.

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