Manager, Quality Assurance Operations, Training and Documentation - Thea Pharma Inc.

MANAGER QUALITY ASSURANCE OPERATIONS (Training and Documentation)

Location: US Headquarters are in Waltham, MA

Position may be remote with required travel as needed.

POSITION SUMMARY

Thea Pharma, Inc. (Thea US) is the newly established US commercial organization of French-based pharmaceutical company, Laboratoires Thea (Clermont-Ferrand). The company has focused on the development and commercialization of OTC and prescription therapeutics for the treatment of eye diseases for over 25 years.

Reporting to the Director, Quality Assurance, the Manager QA Operations will participate in cross-functional teams as a Quality technical resource responsible for managing and providing quality oversight and support to the training program and GxP documentation management process at Thea US.

KEY RESPONSIBILITIES

• Manages the Training program. Develops training materials, quizzes, SCORM files and ensures that training requirements are assigned to personnel.
• Serves as the Document Administrator responsible for the management and control of the GxP documentation, including SOPs, Policies, Forms, and other supporting documentation.
• Serves as the ZenQMS Super User and provides training and support to end users of the system.
• Develop new workflow functionality within QMS System and maintain the system in a continually validated state.
• Serve as a lead for resolution of quality issues related to the programs under his/her responsibility.
• Identify and communicate risks and assist with risk mitigation plans as necessary.
• Collaborate with departments to develop and monitor Key Performance Indicators (e.g. on-time training) to assess performance of the organization and guide continuous improvement efforts.
• Supports regulatory inspections as necessary.

• Communicate and promote a culture of quality and operational excellence.

QUALIFICATIONS

• A Bachelor level degree in Biological Sciences or related subjects is required. Minimum of five years previous industry experience in life sciences, with pharmaceutical experience preferred.
• Problem solving and decision-making skills, and the ability to prioritize and successfully manage complex and competing priorities. 
• Experience with the implementation and/or management of training programs and documentation control processes.
• Experience with EDMS and LMS systems; experience with ZenQMS is a plus.
• Knowledge of FDA and EU regulations as they pertain to 21 CFR Part 11, GAMP 5, and Annex 11 activities is a plus.  
• Demonstrated ability to implement continuous improvement initiatives and ability to communicate clear and concisely both in verbal and written communication.  
• Ability to solve critical issues beyond own responsibilities. Able to work with own team and members of other teams to achieve overall goals.
• Ability to communicate and collaborate with departments across the company.

EDUCATION

Bachelor's degree in life sciences or equivalent

Travel Expectations:

Domestic and International travel may be required (<10%).

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change over time with or without notice.

EEO STATEMENT

Thea Pharma Inc. is proud to be an Equal Employment Opportunity employer. At Thea, we not only support the diversity of our employee population, we celebrate the way our team member’s unique backgrounds and experiences contribute to the success of our company. Thea does not discriminate on the basis of race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Thea Pharma Inc. does not tolerate harassment or discrimination of any kind.

BENEFITS AND PERKS

Thea offers a full suite of employee benefits, including employer-paid health insurance, a generous schedule of paid time off (PTO), Life and Disability insurance, and a 401K retirement program. Thea is a flexible and entrepreneurial work environment where you will enjoy an inclusive culture and the opportunity to have your voice and ideas directly shape the future of the company.

ADDITIONAL INFORMATION

Your information will be kept confidential according to EEO Guidelines.