1+ months

Sr Manager, QA Operations Investigations

Baltimore, MD 21202
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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 Operations 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 that oversee materials management, quality on the floor, batch release and all systems associated with batch release including deviations and change controls 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 Operations and establish a cohesive unit that exercises Quality oversite in partnership with the operations team.
Establish implementation plan for strategic objectives to enhance quality systems compliance across the site, incorporating integration of best practices.
Manage Quality Operations resources that support Camden Project Teams as they relate to client specific projects.
Manage resources to ensure dispositioning of product is 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 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.
Provide broad-based technical guidance in the oversite of validation and production protocol design and execution, ensuring compliance with FDA and global regulations as well as Emergent internal directives.
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 managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelors Degree in Chemistry/Biology or related discipline with 8+ related Quality Assurance experience or a Masters degree with a minimum of 5 to 8 years Quality Assurance experience
Training and understanding of US and OUS regulatory compliance requirements in a commercial manufacturing environment.
Management experience required.
Production experience in a GMP environment a plus.
Working knowledge of process and cleaning validation also a plus.
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

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

Industry

  • Biotechnology
Posted: 2021-11-15 Expires: 2022-06-23

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Sr Manager, QA Operations Investigations

Emergent BioSolutions Inc.
Baltimore, MD 21202
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