Careers

Job Summary

 The Quality Manager will manage day-to-day quality related tasks to fulfill quality and regulatory requirements. Included but not limited to providing full QA/QC support for implementing and maintaining compliance to Current Good Manufacturing Practices (cGMP), Quality Standards at Contract Manufactures with establishing and maintaining quality protocols and quality culture within the Department and Colorescience Inc. This position interacts with higher level management, contract manufacturers, partners, and suppliers. Provide Quality support to R&D, Operations & Marketing Teams. Manage direct reports and internal and external partnerships to ensure efficiency and performance standards are achieved.

Essential Duties and Responsibilities

• Manage and comply with the Company’s Quality System to ensure compliance with cGMP requirements.
• Ensure quality and regulatory compliance with applicable regulations (ex. ICH, CFR21-Part 211, cGMP)
• Manage product release process to ensure compliance to product specifications, domestic and international requirements.
• Manage complaint program (ex. NC, CAPA) and develop new approaches to solve problems identified during investigation process.
• Manage the company’s Adverse Events (AEs) and Products Quality Complaints (PQs), implementing corrective measures and presenting a detailed review to Senior Management.
• Identify and manage the execution of continuous improvement projects.
• Manage Document Control function, SOPs, Product Specification. Oversee and coordinate Quality Training.
• Assure Regulatory compliance to Local, State, Federal, and International Regulatory agencies.
• Hands on oversite of Contract Manufacturing Operations, third party logistics operations and Suppliers.
• Hands on supervision of manufacturing and testing product validation programs, product stability program, overseeing their implementation to ensure that reliable and repeatable processes for manufacturing, filling, packing, and testing are properly executed, and implemented.
• Oversee the Annual Drug Review (ADR) process, assess manufacturing and testing trends and corrective measures when required.
• Hands with company’s Internal and external Audit program. 

Supervisory Responsibilities

Carries out supervisory responsibilities with direct reports in accordance with the organization's policies and applicable laws. Responsibilities include partnering with Human Resources with regards to addressing complaints and resolving concerns.

Education and/or Experience

• Demonstrated technical expertise in, and understanding of cGMPs, CFR21- Part 210 & 211, ICH guidelines and regulatory and audit requirements.
• Bachelor's degree with preference in the science/chemical engineering field with at least 5 years’ experience in leadership role in the pharmaceutical/cosmetic industry with knowledge throughout the product manufacturing and testing cycle.
• Hands-on experience building and managing direct reports.
• Proven ability to develop and maintain relationships with internal and external customers, suppliers, partners, and other stake holders.
• Demonstrated knowledge in working with contract manufacturers, API, and primary component suppliers.
• Experience with pharmaceutical/cosmetic/ manufacturing, laboratory testing, quality control/assurance and regulatory affairs.
• Experience with topical OTC regulated products preferred.
• Proficiency on Microsoft platforms, (Word, Excel, and PowerPoint) is a requirement.

Skills and Abilities

Thorough understanding of, manufacturing, quality control, quality assurance (audit) and regulatory issues related to OTC regulated topical products.

Excellent people and communication skills are a core competency for this position.

Proven record of working with CMO partners to achieve Quality standards.

Knowledge and experience with analytical testing, manufacturing, and packaging operations.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.