- 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.
- 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.
- 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.
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Quality Director - Birmingham, United States - Biote
Description
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
Qualifications for Education and Experience
Preferred Skills
If you're interested in this awesome opportunity, please apply today
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