Quality Director

2 months ago

Birmingham, United States Biote Full time

Biote Medical is the world leader in hormone optimization and we are adding to our team We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.


We are currently looking for a Quality Director to join our team based in Birmingham, AL. This person must be based on-site in Birmingham.


Overview of Position


The Quality Director leads and mentors the quality team and is an integral part of the leadership team at the site in Birmingham, AL. The Quality Director is responsible for the quality and compliance of the site. You will liaise Regulatory Agencies such as the United States Food and Drug Administration and other Health Authorities, including hosting inspections and responding to regulatory inquiries.


This role is responsible to direct all QA initiatives for the site. You will manage and coordinate the activities of the assigned team in alignment with site and organizational objectives. You will hire, coach, train, and develop skills of the subordinate staff. Staff may include salaried and/or hourly non-exempt employees.


This position will ensure that the operation of the facility and the equipment are in compliance with standards described under Sections 503B of the US Food, Drug & Cosmetic Act, OSHA, environmental, labor, and other governmental laws and regulations, while following appropriate documentation and quality systems.


Essential Duties and Responsibilities


  • Manages and coordinates QA staff and/or consultants towards the timely completion of assigned duties and responsibilities.
  • Ensures compliance with US Food, Drug & Cosmetic Act, Section 503B, and all of its cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports, and records.
  • Assists with all aspects of quality systems, such as Change Control, Investigations, Corrective/Preventive Action, Validation systems to ensure compliance and timely and accurate completion of reporting events.
  • Designs and maintains the environmental monitoring program including environmental and personnel monitoring results.
  • Participates in internal/external supplier qualification audits and regulatory inspections.
  • Trains personnel on appropriate aseptic and gowning techniques.
  • Manages and/or executes the planning, conducting, and reporting of QA batch disposition functions for cGMP manufacturing and distribution activities.
  • Prepares, reviews, and approves controlled documents relevant to company operations.
  • Performs duties in accordance with established company procedures and policies; performs other duties as assigned.


Qualifications for Education and Experience


  • Legally authorized to work in the job posting country.
  • BS in Engineering, Microbiology, or Sciences, and/or equivalent experience.
  • 5-7 years of progressive experience within cGMP quality operations and FDA regulations.
  • Well-versed in the compliance and quality requirements of 503B pharmaceutical industry and cGMPs.
  • Familiarity with manufacturing processes and operations with a strong focus on equipment and facilities validation.
  • Recent experience with validation of aseptic drug product bulk manufacturing processes.
  • Experience in environmental monitoring of clean rooms, aseptic media fill evaluation, bioburden, sterility and endotoxin testing of raw materials, in-process samples, and bulk/finished product testing according to USP.
  • Prior experience in greenfield projects or facility startups is preferred.


Preferred Skills


  • Strong communication skills with the ability to interact with all levels throughout the organization.
  • Demonstrated ability of successful leadership, influence, and negotiation a plus.
  • Proficient in Microsoft Office.
  • Understanding of Lean Six Sigma principles.
  • Strong background in quality management systems.
  • Excellent organizational, leadership, motivational, analytical problem solving, and strategic thinking skills.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced environment with dynamic priorities and demands.


If you're interested in this awesome opportunity, please apply today

  • Quality Director

    2 weeks ago

    Birmingham, United States Biote Full time

    Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health. We are currently looking for a Quality Director to...

  • Quality Director

    1 week ago

    Birmingham, United States Biote Full time

    Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health. We are currently looking for a Quality Director to...

  • Quality Director

    2 weeks ago

    Birmingham, United States Biote Full time

    Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health. Read the overview of this opportunity to understand...

  • Quality Director

    2 months ago

    Birmingham, United States Biote Full time

    Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.We are currently looking for a Quality Director to...

  • Quality Director

    2 days ago

    Birmingham, United States Biote Full time

    Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.We are currently looking for a Quality Director to...

  • Graphic Designer

    1 week ago

    Birmingham, United States Quality Roots Full time

    Job DescriptionJob DescriptionPosition Summary:Quality Roots is quickly growing in the Michigan cannabis industry and seeks to hire an experienced Graphic Designer to help promote our unique brands, products, store locations and our cannabis lifestyle through various forms of marketing initiatives using your graphic design skills.The Graphic Designer will...

  • Graphic Designer

    2 days ago

    Birmingham, United States Quality Roots Full time

    Job DescriptionJob DescriptionPosition Summary:Quality Roots is quickly growing in the Michigan cannabis industry and seeks to hire an experienced Graphic Designer to help promote our unique brands, products, store locations and our cannabis lifestyle through various forms of marketing initiatives using your graphic design skills.The Graphic Designer will...

  • Quality Engineer

    1 month ago

    Birmingham, United States Certified Aviation Services LLC Full time

    Job DescriptionJob DescriptionDescription:Job Description – Certified Aviation Services, LLCTitle: Quality Engineer Reports to: Director of Quality, Training, Safety, & ComplianceBased at: BHM - AlabamaRole Type: Full TimePosition Summary: Will be responsible for developing Quality protocols and support monitoring all applicable certifications within the...

  • Quality Engineer

    2 days ago

    Birmingham, United States Certified Aviation Services LLC Full time

    Job DescriptionJob DescriptionDescription:Job Description – Certified Aviation Services, LLCTitle: Quality Engineer Reports to: Director of Quality, Training, Safety, & ComplianceBased at: BHM - AlabamaRole Type: Full TimePosition Summary: Will be responsible for developing Quality protocols and support monitoring all applicable certifications within the...

  • Medical Director

    2 weeks ago

    Birmingham, United States Removery Full time

    About Removery: Join us in our journey of normalizing tattoo removal around the world! Removery is an innovative, collaborative laser tattoo removal company. We take pride in our mission to make a real difference in people's lives by supporting them as they embrace change through their tattoo removal journey. Our vision is to remain professional, genuine,...

  • Medical Director

    2 days ago

    Birmingham, United States Removery Full time

    About Removery: Join us in our journey of normalizing tattoo removal around the world! Removery is an innovative, collaborative laser tattoo removal company. We take pride in our mission to make a real difference in people's lives by supporting them as they embrace change through their tattoo removal journey. Our vision is to remain professional, genuine,...

  • Regional Director of Operations

    7 days ago

    Birmingham, United States Behavioral Health Group - BHG Full time

    We are specifically seeking candidates who currently reside in Alabama. The Regional Director of Operations is a business unit owner and is responsible for maximizing BHG clinical and financial performance in an assigned territory. The Regional Director supervises the daily operations to include the direct supervision of the treatment center's Program...

  • Regional Director of Operations

    7 days ago

    Birmingham, United States Behavioral Health Group - BHG Full time

    We are specifically seeking candidates who currently reside in Alabama. The Regional Director of Operations is a business unit owner and is responsible for maximizing BHG clinical and financial performance in an assigned territory. The Regional Director supervises the daily operations to include the direct supervision of the treatment center's Program...

  • Director of Laboratory Operations

    1 month ago

    Birmingham, United States Community Health System Full time

    Job Description Directs, establishes, and plans the overall policies and goals for a hospital's laboratory services. Works closely with hospital staff, department directors, and physicians to ensure the highest standards of quality and service are maintained. Writes and updates procedures and manuals as needed and reviews them annually to ensure that...

  • Director of Laboratory Operations

    2 days ago

    Birmingham, United States Community Health System Full time

    Job Description Directs, establishes, and plans the overall policies and goals for a hospital's laboratory services. Works closely with hospital staff, department directors, and physicians to ensure the highest standards of quality and service are maintained. Writes and updates procedures and manuals as needed and reviews them annually to ensure that...

  • Director of Nursing

    1 month ago

    Birmingham, United States Regency Retirement Community of Birmingham Full time

    Regency Senior Living is a Non-Mandate Company Overview: The Director of Nursing oversees all medical and care needs for the residents. The director oversees all Department Staff. Ensures overall mission of Regency Senior Living is fulfilled. Responsibilities: Nursing: * Maintains weekly QA and Incident Report Logs for the State of AL * Conducts and...

  • Director of Nursing

    2 days ago

    Birmingham, United States Regency Retirement Community of Birmingham Full time

    Regency Senior Living is a Non-Mandate Company Overview: The Director of Nursing oversees all medical and care needs for the residents. The director oversees all Department Staff. Ensures overall mission of Regency Senior Living is fulfilled. Responsibilities: Nursing: * Maintains weekly QA and Incident Report Logs for the State of AL * Conducts and...

  • Funeral Director

    2 weeks ago

    Birmingham, United States Everstory Partners Full time

    Job DescriptionJob DescriptionDescription:Why EverstoryAt Everstory Partners, our mission is to create supportive spaces where individuals and families can find solace, meaning, and hope in the midst of loss. At the heart of our mission is a deep understanding of the profound and complex nature of grief. Every person’s journey through loss is unique, and...

  • Aviation Quality Engineer

    3 days ago

    Birmingham, United States Certified Aviation Service LLC (LMG) Full time

    Description:*Job Description – Certified Aviation Services, LLC**Title*: Aviation Quality Engineer*Reports to:* Director of Quality, Training, Safety, & Compliance*Based at:* BHM - Alabama*Role Type:* Full Time*Position Summary:*Will be responsible for developing Quality protocols and support monitoring all applicable certifications within the...

  • Aviation Quality Engineer

    2 days ago

    Birmingham, United States Certified Aviation Services Full time

    Description: *Job Description Certified Aviation Services, LLC* *Title*: Aviation Quality Engineer *Reports to:* Director of Quality, Training, Safety, & Compliance *Based at:* BHM - Alabama *Role Type:* Full Time *Position Summary:* Will be responsible for developing Quality protocols and support monitoring all applicable certifications within the...