Federation of American Societies for Experimental Biology (FASEB)

Sr. Manager, Quality Assurance

AGC Biologics
Longmont, Colorado, United States
11 days ago

Description

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

Summary 

AGC Biologics Quality team is looking for a Senior Manager, Quality Assurance.  This position is responsible for the Management of the Quality Operations for Adjuvant Manufacturing and will be instrumental in the establishment of quality processes supporting this new manufacturing operation.  We are looking for a passionate individual who can excel in a dynamic environment and who can provide leadership and technical mentorship to the Quality team.



Requirements

KEY RESPONSIBILIES:

  • Ensuring site Quality Operations policy and procedures are in place, are maintained current to corporate and regulatory requirements, and effectively meeting the needs of GMP Operations.
  • Provide strong leadership, development, and oversight of direct/indirect reports
  • Proactively address GMP compliance concerns and resolve problems
  • Provide in plant QA support for Manufacturing adjuvant
  • Review and approve executed batch production records and product testing records
  • Work on complex problems that involve groups outside of QA as well as clients
  • Diplomatically partners with other departments/groups for corrections and problem solving
  • Review and approve deviations and corrective actions
  • Review and approve site SOPs, master batch records and test methods related to adjuvant production
  • Review and approve test method and process validation documents
  • Participate in GMP-related problem resolution
  • Provides direct supervision to exempt employees and/or skilled nonexempt employees
  • Manages QA support for the review and approval batch records
  • Assigns daily/weekly tasks to staff
  • Use best practices in training development and coaching
  • Performance appraisals
  • Represent QA department in cross-functional teams
  • Participate in and facilitates teams supporting regulatory inspection readiness
  • Other duties as assigned

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong verbal and written communications skills
  • Excellent analytical and problem-solving skills
  • Ability to seamlessly manage a variety multiple project simultaneously
  • Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company
  • Deeply well organized, flexible, and responsive
  • Good judgement with strong interpersonal relationship, team building, and collaboration skills
  • Willing and able to travel

 EDUCATION/EXPERIENCE:

  • Bachelors of Science in chemistry or life sciences or equivalent experience.
  • 8+ years of relevant experience in a pharmaceutical or FDA/GMP environment.
  • Experience with vaccine or adjuvant manufacturing preferred or cell based production and purification technologies.
  • Management experience.
  • Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
  • Experience in review of test method validation, equipment qualification and process validation preferred.
  • Demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, results-oriented.

COMPENSATION RANGE:

$121,844 - $159,615


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

Job Information

  • Job ID: 58633768
  • Location:
    Longmont, Colorado, United States
  • Company Name: AGC Biologics
  • Position Title: Sr. Manager, Quality Assurance
  • Job Function: Quality Assurance Specialist
  • Min Experience: 7-10 Years
  • Salary: $121,844.00 - $159,615.00 (Yearly Salary)
Biotechnology
Boulder , CO , US

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases.   AGC Biologics purchased a state-of-the-art commercial m...

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