Sr. Manager, Quality Assurance

Location: 

Baltimore, MD, US, 21230


 

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.

I.    JOB SUMMARY 
Responsible for managing the implementation of long-range goals, strategies, plans and policies as they relate to the management of Quality Assurance to ensure cGMP compliance.  Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.  This position is responsible for the management of the teams or individuals that oversee the following functional areas: internal/external audits, change controls, document control, electronic QMS, QA oversight of equipment/facilities/CSV, regulatory compliance/state licensing/DEA controlled substance, supplier quality, training, etc.

 

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
General Management
•    Manage multiple functional groups within Quality Assurance and establish a cohesive unit that exercises Quality oversight in partnership with site QA Operations, QC, and Operations teams.
•    Lead site Quality Systems departments to achieve and exceed department responsibilities and objectives
•    Establish implementation plan for strategic objectives to enhance quality systems compliance across the site, incorporating integration of best practices.
•    Manage Quality Assurance resources that support Camden Project Teams as they relate to client specific projects.
•    Manage resources to support dispositioning of product in conformance with Emergent requirements and meets site goals and client needs.
•    Collaborate with other functional area goals and priorities by soliciting information from those functional groups during development of departmental objectives.
•    Coach and mentor employees through problems of diverse scope in which analysis of situations or data requires evaluation of intangible factors and directs subordinates to complete assignments through interpretation of established GXP guidelines.
•    Responsible for direct reports as it pertains to personnel management, guidelines, training, disciplinary and performance appraisals.
General Responsibilities
•    Exercise judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
•    Make decisions based upon assessment of information from many sources including customers, manufacturing processes, QC testing, and other available information.
•    Represent the department in interactions with internal functional units and external contract partners, or regulatory officials during site audits.
•    Apply in-depth skill and broad knowledge of business to address complex problems and non-standard situations to include the adoption of new technologies.
•    Develop lifecycle and systems-based approach to the design and implementation of Quality Systems and process controls in conformance with regulatory compliance and corporate guidelines.
•    Provide strategic technical guidance and management support for quality functions minimizing workload, optimizing resources, streamlining existing systems, and contributing to continuous improvement opportunities.

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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree in Chemistry/Biology or related discipline with 8+ years related Quality Assurance experience or a Master’s degree with a minimum of 5 to 8 years Quality Assurance experience
•    2-3+ years’ experience managing and developing people leaders
•    Training and understanding of US and international regulatory compliance requirements in a commercial manufacturing environment
•    Working knowledge of GMP manufacturing or packaging environments
•    Must have strong attention to detail and demonstrated decision-making ability
•    Ability to manage multiple priorities and tasks in a dynamic environment
•    Excellent written and verbal skills
•    Ability to exercise judgment to determine appropriate corrective actions
•    Ability to use computer programs
•    Ability to work in a team environment
•    Ability to work and communicate with clients
•    Ability to supervise direct reports and manage assigned activities

 

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore