What are the responsibilities and job description for the QA & Regulatory Compliance Manager position at Pharmiweb?
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
Physical Requirements :
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.
