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Manager Quality Assurance

Company: TherapeuticsMD, Inc.
Location: Boca Raton
Posted on: September 19, 2022

Job Description:

Job Summary

The Quality Assurance Manager will be responsible for providing subject matter expertise and technical support in product manufacture, release and testing activities. This support includes building and implementing a robust and sustainable strategy which will provide assurance that produced product consistently meets GMP and regulatory requirements. This is accomplished by developing, improving, and/or implementing processes, concepts and strategies relative to this function.

Essential Duties and Responsibilities

* Assure that testing activities including, process validation, commercial product release and commercial stability are performed according to regulatory commitments and defined protocols.
* Review and perform quality control checks of CMC documents in support of regulatory filings and finished product release.
* Perform QA oversight, reviews and audit of process documentation associated with product manufacturing, packaging, and testing to assure timely availability of materials
* Work with external contract service providers to identify process-impacting deviations and investigations and ensure prompt documentation and communication to Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
* Review investigations and deviations that may impact product quality and make fact based recommendations regarding material dispositions. Aid in identifying potential corrective actions and track to ensure completion.
* Investigate and address identified compliance and quality issues and develop solutions to correct known and potential compliance and quality concerns.
* Oversee the change control processes.
* Partner with multiple cross-functional groups, including external contract services providers, to drive process/product related improvements
* Collaborate with external test labs to ensure the design and execution of test methods is consistent with company policies/procedures and regulatory filings.
* Promote a culture that supports continuous improvement through active communication and functional area participation. Facilitate GMP training of functional areas and develop appropriate training for personnel involved in the execution of commercial drug product management.
* Collaborate with other QA colleagues to ensure GMP training and Inspection Awareness/Readiness training are performed
* Act as back-up inspection host or back-room support as assigned for any GMP-related inspections.

Other Duties

Other duties, responsibilities and activities may be assigned.

Required Qualifications

* Strong knowledge of Quality Assurance, GMPs, Quality Systems and Health Authority Regulations
* Hands-on experience reviewing laboratory testing data, trending and statistical analysis.
* Knowledge of industry standards in Quality and equipment utilized in the testing and development of pharmaceutical products.
* Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
* Ability to interpret and relate Quality standards for gap analysis
* Ability to communicate clearly and professionally both in writing and verbally
* Flexibility in problem solving, providing direction and work hours to meet business objectives
* Ability to effectively assess project timelines and assess resource requirements and provide recommendations to management
* Demonstrate the ability to anticipate problems before they become critical and involve management when appropriate.
* Demonstrate excellent interpersonal skills including the ability to resolve conflicts with poise, diplomacy and tact. Work effectively as part of a team and collaborate with staff at all levels.
* Ability to develop and propose strategies for Quality oversight and improvements, and understand strategic impact of decisions.
* Ability to influence project team members and contract manufacturers in order to successfully achieve compliance with Quality requirements.
* Ability to present and defend QA programs and strategy to peers, management, internal groups and regulatory authorities.
* Experience with reviewing stability data and performing data trending.
* Understands the validation process and regulatory expectations
* Accountable for projects, decisions, and communication.

Required Education

* BS degree in Chemistry, or a related scientific discipline.
* 10+ years of related experience in the area of CMC / Pharmaceutical Quality Assurance and/or Control within the pharmaceutical industry.
* 3 years of experience working with Contract Manufacturing Organizations with respect to quality assurance activities.

Physical functions

* The employee is occasionally required to sit, climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 35 pounds.
* Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

* This job operates in a professional office environment.
* This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
* Some of the work will require exposure to loud noises and exposure to pharmaceutical manufacturing and laboratory environments.

Travel

This position requires up to 35% travel. Travel includes out of the area, overnight and international.

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.

Keywords: TherapeuticsMD, Inc., Boca Raton , Manager Quality Assurance, Executive , Boca Raton, Florida

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