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QA & Regulatory Compliance Manager

3 months ago

Carlsbad, United States Galderma S.A. Full time

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

The Company:

ALASTIN Skincare, Inc. is the fastest-growing physician-dispensed skincare company in the U.S. with innovative, scientifically proven and clinically tested products. Founded in 2015 and located in Carlsbad, CA, the company provides a comprehensive collection of cutting-edge products for optimal procedure results and daily skincare regimens. Following our recent acquisition by Galderma, the world's largest independent dermatology company, Alastin has continued its rapid growth operating as an independent business unit of Galderma

Position Summary:
The Quality Assurance and Regulatory Compliance Manager is responsible for product quality, manufacturing compliance, customer claims, vendor audits, safety SOPs, and continuous quality improvement process to meet higher quality standards and achieve customer expectations. This position will inspect products, vendors, processes and procedures to ensure consistency and compliance. This position will report to the Associate Director, Quality Assurance & Regulatory Compliance.

Responsibilities:

  • Oversee product quality and packaging specifications, review inspection reports, and support in-house production quality compliance assemblies
  • Review cGMP documents to ensure compliance
  • Manage and review QA performance data regularly, as well as product statistical reports, present and suggest actions to management
  • Oversee testing procedures to ensure that products comply with set specifications
  • Batch records review and creation of Certificate of Conformity.
  • Write and implement Standard Operating Procedures
  • Manage and implement document change controls
  • Manage deviation control process
  • Train and support QA team on quality procedures, protocols, and documentation
  • Communicate quality concerns to management
  • Coordinate investigation of quality issues with customers and suppliers
  • Review, approve and communicate root cause and corrective action to stakeholders regarding quality issues
Requirements
  • 5 or more years of experience in QA/Regulatory management required
  • 3 or more years of experience in cGMP/FDA/ISO and regulated OTC products
  • Experience in Health & Beauty industry is preferred
  • BA/BS degree required, or equivalent education and directly related years of experience.
  • Cosmetic ingredient and regulations knowledge
  • Thorough knowledge of quality assurance and standards, methodologies
  • Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts
  • Ability to think strategically and be extremely detail oriented
  • Demonstrated ability to work in a team oriented, collaborative environment
  • Ability to multi-task, prioritize, and manage time effectively.
  • Effective goal setting, budgeting, planning and analyzing information and metrics, relationship-building, and strong problem-solving skills
  • Experience working with NetSuite, or other ERP system, order entry portal, or CRM system
  • Experience working with eQMS systems (TrackWise etc.)
  • Proficient in Microsoft PowerPoint, Word, and Excel
  • Ability to work cross-functionally with other departments with the ability to manage upwards and downwards
Physical Requirements:
  • Must be able to remain in a stationary position for long periods of time
  • The person in this position needs to occasionally stoop, bend, and kneel
  • Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer
  • Ability to consistently lift/move inventory in excess of 50 pounds.
  • Must be able to perform the physical tasks required by the position


Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.