Website TherapeuticsMD
For Her. For Life.
Responsible for product quality complaint processing and oversight focusing on daily investigations of complaints. This role will provide daily support to the Quality Management System (QMS) owner and will provide broad support to the Quality Systems team as needed. Candidate will be responsible for utilizing the electronic Quality Complaints module including all related transactional activities. Support may also include review of change controls, deviations, investigations, batch records, analytical data, CoAs, and SOPs and requires interaction with Technical Services, R&D, QA, Regulatory, and other internal departments, and external contract service providers as needed. This role is intended to maintain process control and requires, at times, to take independent action to ensure work is done accurately and completely.
Duties & Responsibilities –
- Responsible for entry of received product quality complaints into the electronic complaint system
- Perform complaint classification and severity assignment
- Issue management notifications for critical complaints
- Facilitate sample return with Designated POC/ Logistics for return product assessments
- Collaborate with site operations for investigations
- During investigation review ensure the execution is consistent with company policies, procedures, and regulatory filings.
- Generate and distribute response letters, as applicable
- Provides monthly reconciliation and trending lists to management review board
- Perform unit trending for complaints in support of quarterly metrics reporting
- Support ad hoc requests regarding complaints (as appropriate)
- Partner with multiple cross-functional groups, including external contract service providers to drive process and product related improvements associated with confirmed complaint issues (as needed).
- Promote a culture that supports continuous improvement through active communication and functional area participation.
- Responsible for providing training as SME on complaint process (as needed)
- Responsible for maintaining complaint SOPs, Work Practices, Job Aids and training materials
- Support enhancements and upgrades to complaint system and perform user acceptance testing
- Assist with quality review of change controls associated with the complaint process
- Assist in the execution of the various QA systems including trending and information reporting
- Other duties, responsibilities and activities may be assigned
Qualifications –
- Minimum of 3 years of pharmaceutical industry experience directly related to QA/Regulatory Compliance; working knowledge of cGMPs and FDA/ICH guidelines.
- Experience performing investigations and root cause analysis;
- Ability to write reports, business correspondence, and standard operating procedures
- Ability to effectively (diplomatically) present information and respond to questions from groups of managers, third party contractors and customers.
- Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.
- Ability to work a flexible work schedule to accommodate program and project priorities as needed.
- Excellent written and verbal communication skills
- Previous direct experience working with electronic systems such as Veeva, TrackWise, SharePoint or similar software applications
- Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
- Strong competency in MS Office product and Adobe Acrobat
- Ability to work effectively/congenially; both independently and with a multidisciplinary team.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- BA/BS in Life Science field of study
TherapeuticsMD, Inc. is an Equal Opportunity Employer. Qualified applicants are considered for employment without regard to race, color, age, national origin, religion, marital status, sex, sexual orientation, gender identity, gender expression, genetics, disability, protected veteran status or any other basis prohibited by law. We are committed to a diverse and inclusive workplace.