Manager Quality Assurance
Company: TherapeuticsMD, Inc.
Location: Boca Raton
Posted on: September 19, 2022
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
* 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
* Oversee the change control processes.
* Partner with multiple cross-functional groups, including external
contract services providers, to drive process/product related
* 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
* 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, responsibilities and activities may be assigned.
* 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
* Ability to interpret and relate Quality standards for gap
* Ability to communicate clearly and professionally both in writing
* 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
* 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
* 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
* Understands the validation process and regulatory
* Accountable for projects, decisions, and communication.
* 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
* 3 years of experience working with Contract Manufacturing
Organizations with respect to quality assurance activities.
* 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.
* This job operates in a professional office environment.
* This role routinely uses standard office equipment such as
computers, phones, photocopiers, filing cabinets and fax
* Some of the work will require exposure to loud noises and
exposure to pharmaceutical manufacturing and laboratory
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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