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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[510,517,525,539,550],{"_429":428,"_434":511,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":512,"_431":432,"_433":194,"_454":453,"_442":443,"_425":513,"_455":456,"_430":115,"_476":514,"_460":515,"_478":512,"_479":443,"_481":482,"_483":484,"_485":516},["D",1771372800000],"Quality Director - Sterile Manufacturing",["B","2620663432"],"1 days ago","/jobs/2620663432-quality-director-sterile-manufacturing","/jobs?keyword=Quality+Director+-+Sterile+Manufacturing",{"_429":428,"_434":518,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":519,"_431":432,"_433":194,"_454":453,"_442":520,"_425":521,"_455":456,"_430":115,"_476":514,"_460":522,"_478":519,"_479":520,"_481":482,"_483":523,"_485":524},["D",1771372800000],"Quality Director - Pharmaceutical Manufacturing","Fort Worth, TX, US, 76102",["B","2619489964"],"/jobs/2619489964-quality-director-pharmaceutical-manufacturing","/jobs?location=Fort+Worth%2C+TX%2C+US%2C+76102","/jobs?keyword=Quality+Director+-+Pharmaceutical+Manufacturing",{"_429":428,"_434":526,"_452":453,"_444":527,"_243":528,"_441":529,"_427":428,"_111":530,"_431":194,"_433":194,"_454":453,"_442":531,"_425":532,"_455":533,"_430":115,"_476":534,"_460":535,"_478":530,"_479":531,"_481":536,"_483":537,"_485":538},["D",1770472800000],"A-Line Staffing Solutions LLC","A-Line Staffing is now hiring a Quality Director in Dallas, TX!\nThe Quality Director will be working for a respected pharmaceutical manufacturing organization and has strong long-term growth potential. See additional details below.

Quality Director Highlights\nPay Rate: $160,000-$170,000 annually

Schedule:

Monday through Friday

Work Setting:

Onsite position

Employment Type:

Full-Time, Exempt

Responsibilities\nServe as the senior Quality leader and technical Subject Matter Expert (SME) for sterile parenteral manufacturing within a 503B Outsourcing Facility.

Own and execute regulatory strategy in alignment with FDA guidance, USP

, USP

, USP

, and cGMP requirements (21 CFR Parts 210/211).

Lead all regulatory inspections and external audits as the primary Management Representative.

Drive continuous inspection readiness across facilities, documentation, training, and validation programs.

Translate regulatory and compliance requirements into scalable quality systems and operational controls.

Oversee batch record review, product disposition, and release of compounded sterile products.

Lead deviation management, CAPA, change control, complaints, investigations (OOS/OOT), and recall readiness.

Ensure SOPs, validation protocols, qualification documentation, and environmental monitoring programs meet regulatory expectations.

Review and approve validation strategies for equipment, processes, utilities, and facilities.

Establish data-driven quality metrics and continuous improvement initiatives.

Maintain compliance with Wholesale Drug Distribution regulations and licensing requirements.

Ensure traceability, documentation integrity, and audit readiness across distribution operations.

Build, mentor, and develop high-performing Quality teams.

Promote a culture of accountability, compliance ownership, and operational excellence.

Requirements\nBachelor’s degree in Engineering, Life Sciences, or a related discipline required.

Master’s degree, PharmD, or MBA preferred.

Minimum

8+ years

of hands-on experience in aseptic processing of sterile drugs for human use.

Minimum

5+ years

of progressive leadership experience managing Quality functions or organizations.

Expert-level knowledge of:\nFDA Section 503B and related guidance

USP

, USP

, and USP

State Board of Pharmacy regulations applicable to outsourcing facilities

21 CFR Parts 210/211 and cGMP requirements

Proven success leading FDA inspections and regulatory audits.

Strong technical writing, documentation, and cross-functional leadership skills.

Benefits Available\nBenefits are available to full-time employees after 90 days of employment.

A 401(k) with company match is available for full-time employees with 1 year of service on eligibility dates.

If you are interested in this

Quality Director

position,

APPLY

, or contact

kvaughn@alinestaffing.com

for more information.\n","A-Line Staffing is now hiring a Quality Director in Dallas, TX!\nThe Quality Director will be working for a respected pharmaceutical manufacturing o...","Quality Director {166131}","Dallas, Texas, United States",["B","2473587704"],"Work at A-Line Staffing Solutions LLC","11 days ago","/jobs/2473587704-quality-director-166131","/jobs?keyword=A-Line+Staffing+Solutions+LLC","/jobs?location=Dallas%2C+Texas%2C+United+States","/jobs?keyword=Quality+Director+%7B166131%7D",{"_429":428,"_434":540,"_452":453,"_444":541,"_243":438,"_441":438,"_427":428,"_111":542,"_431":432,"_433":194,"_454":453,"_442":543,"_425":544,"_455":545,"_430":115,"_476":514,"_460":546,"_478":542,"_479":543,"_481":547,"_483":548,"_485":549},["D",1771372800000],"Berkshire Sterile Manufacturing","Director of Quality Operations","Lee, MA, US, 01238",["B","2619527838"],"Work at Berkshire Sterile Manufacturing","/jobs/2619527838-director-of-quality-operations","/jobs?keyword=Berkshire+Sterile+Manufacturing","/jobs?location=Lee%2C+MA%2C+US%2C+01238","/jobs?keyword=Director+of+Quality+Operations",{"_429":428,"_434":551,"_452":453,"_444":445,"_243":552,"_441":553,"_427":428,"_111":519,"_431":432,"_433":194,"_454":453,"_442":520,"_425":554,"_455":456,"_430":115,"_476":555,"_460":556,"_478":519,"_479":520,"_481":482,"_483":523,"_485":524},["D",1771286400000],"

NOW HIRING: Quality Director – 503B Pharmaceutical Manufacturing\n \n Location:\n \n Onsite – Dallas, TX\n Schedule:\n \n Monday–Friday, Onsite\n Salary:\n \n $150,000–$160,000 per year\n Relocation:\n \n Candidates must already live in OR near Dallas, TX or be willing to relocate at their own expense (no relocation assistance)\n Benefits:\n \n Full benefits package\n \n Overview\n We are looking for an experienced\n \n Quality Director\n \n to lead the Quality function at a fast-growing\n \n FDA-registered 503B Outsourcing Facility\n \n . This is a\n \n senior leadership role\n \n for someone with deep experience in\n \n sterile pharmaceutical manufacturing\n \n who wants ownership over quality systems, compliance, and inspection readiness.\n You will be the go-to expert for\n \n 503B regulations, aseptic processing, and FDA compliance\n \n , working closely with manufacturing and operations to ensure the highest quality standards are met.\n This is a hands-on, onsite leadership role in a high-growth environment.\n \n JOB SUMMARY:\n Quality & Regulatory Leadership\n Serve as the primary quality and regulatory expert for sterile drug manufacturing\n Lead compliance with FDA 503B requirements, USP\n \n , USP\n \n , USP\n \n , and cGMPs (21 CFR 210/211)\n Turn regulatory requirements into clear, practical quality systems\n Inspection & Audit Readiness\n Lead FDA inspections and external audits\n Ensure the facility is always inspection-ready\n Partner closely with Manufacturing, Engineering, Validation, and Operations teams\n Quality Systems & Operations\n Oversee batch record review, product release, and disposition\n Lead investigations, deviations, CAPAs, change controls, complaints, and recalls\n Ensure SOPs, validation documents, and environmental monitoring programs are current and compliant\n Validation & Continuous Improvement\n Review and approve validation plans for equipment, processes, utilities, and facilities\n Use quality metrics and data to drive continuous improvement\n Distribution Compliance\n Maintain compliance with wholesale drug distribution requirements\n Ensure documentation accuracy and traceability\n People Leadership\n Build, mentor, and lead a high-performing Quality team\n Promote a culture of accountability, compliance, and excellence\n \n REQUIREMENTS:\n Bachelor’s degree in Engineering, Life Sciences, or related field\n 8+ years of experience in aseptic sterile drug manufacturing\n 5+ years of leadership experience in Quality or Compliance\n Strong working knowledge of: FDA 503B regulations; USP\n \n , USP\n \n , USP\n \n ; cGMP (21 CFR 210/211)\n Proven experience leading FDA inspections\n Master’s degree, PharmD, or MBA\n Experience in fast-growing pharmaceutical or compounding environments

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NOW HIRING: Quality Director – 503B Pharmaceutical Manufacturing\n \n Location:\n \n Onsite – Dallas, TX\n Schedule:\n \n Monday–F...",["B","2619395865"],"2 days ago","/jobs/2619395865-quality-director-pharmaceutical-manufacturing","actionData","errors"]