Director Quality Assurance Operations
Director Quality Assurance Operations
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$ 164400 - 226050
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
JOB SUMMARY:
We are seeking an experienced and strategic Director of Quality Assurance to lead our QA Operations team and play a key role in shaping the future of our manufacturing site. This position is critical to ensuring compliance with cGMP standards and regulatory requirements while also supporting our development into commercial manufacturing and the advancement of developmentstage products.
In this role you will oversee daily QA operations including lot disposition and serve as a trusted partner to crossfunctional teams in Manufacturing Facilities and Quality Control. You will also champion continuous improvement initiatives aimed at increasing operational efficiency and maintaining the highest standards of product quality.
PRINCIPAL RESPONSIBILITIES:
- Develops establishes and maintains quality assurance programs and systems processes procedures and controls ensuring that performance and quality of products conform to established phaseappropriate cGMP standards and regulatory requirements.
- Develops implements and maintains quality systems (e.g. disposition) required for commercial and clinical operations from cGMP and operational efficiency perspectives.
- Manages QA support for the review and approval of documentation such as batch records process and equipment validation protocols and reports product specifications and change controls.
- Evaluates proposed process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory guidelines and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
- Provides expertise and guidance in interpreting existing and emerging governmental regulations agency guidelines and internal policies to assure compliance.
- Leads and supports investigations associated with major deviations in operations.
- Represents the company in dealing with clients and leads the negotiation of quality agreements.
- Partners with Manufacturing Engineering and QC to enhance the GMP compliance profile of the site by ensuring the timely closure of investigations and implementation of appropriate corrective actions.
- Ensures that all trends are evaluated that root causes are identified and that corrective actions are implemented.
- Authors reviews and/or approves internal quality documents (SOPs deviations CAPAs change controls etc. and external regulatory agency documents.
KNOWLEDGE SKILLS AND ABILITIES:
- Ability to understand and apply GMP regulations as they relate to manufacturing raw materials testing and facility operations.
- Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills selfmotivated.
- Strong interpersonal written and oral communication skills.
- Strong problemsolving skills.
- Strong management staff development and mentoring skills.
EDUCATION AND EXPERIENCE:
- Bachelors degree in Physical Sciences Life Sciences or Engineering; an advanced degree is preferred.
- 12 years of relevant experience in a biotechnology and GMP environment.
- Experience with QA and GMP compliance in clinical and commercial drug substance manufacturing.
COMPENSATION RANGE:
$164400 $226050
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Director
Employment Type
Full-Time
