Sr. Manager Quality Assurance

Location
San Diego, CA, US
Posted
Dec 15, 2020
Ref
698984000
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position Summary

The Sr. Manager Quality Assurance will be responsible for providing leadership, management, and oversight to all Quality Assurance functions. The QA manager will develop and maintain systems/processes to ensure compliance with Emergent and Regulatory requirements and expectations. The Sr. Manager QA will lead the initiatives for process harmonization and Quality Standards implementation as it relates to cGMP phase appropriate adherence at Emergent SD site. The role will serve as a lead and liaison across Emergent global network driving the initiatives for quality events process improvements and implementation.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Review and approve, as necessary, Standard Operating Procedures, analytical test methods, batch records, specifications, protocols, technical transfer packages and other documentation used in the development, manufacturing, packaging, testing and distribution of early phase Clinical Trial Materials.
  • Audit manufacturing, laboratory, labeling and packaging records and other documentation associated with the manufacturing, packaging, testing and distribution of product
  • Maintain and Provide Oversight of Quality Assurance Systems including: Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; Batch Record Review; Product Release
  • Review and approve Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Batch Records and other GMP documentation
  • Maintain and manage internal audit program and perform internal audits.
  • Provide input and develop content of GxP training materials for GMP and GCLP functional groups
  • The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.


MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • Bachelors of Science in Biology, Chemistry, Physical Sciences, or related degree.
  • Minimum 8 years in GxP (GMP and GCLP) pharmaceutical environment in progressively responsible Quality roles. Highly desirable to have a minimum of 5 years of Quality Systems experience.
  • Solid understanding of US and European regulations including application in the day to day environment.
  • Previous experience working with FDA and participating in regulatory agency inspections
  • S olid problem solving and critical thinking skills
  • Strong interpersonal, verbal and written communication skills
  • Ability to work well in a fast-paced, team-oriented environment
  • Excellent organizational ability - can easily multi-task and shift priorities as needed
  • Attention to details
  • Works independently with moderate supervision
  • Must have good written and verbal communication skills. The ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups.
  • Experience in vaccines development and manufacturing is a plus.
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.


There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

.buttontextd24067979861e38d a{ border: 1px solid transparent; } .buttontextd24067979861e38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }