Manager Quality Assurance

Location: 

Dublin, IE


 

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.

Reporting directly to the Director, Quality, Manager, Quality Assurance will be responsible for the management of Quality and Compliance functions for Emergent (EBSI) products and/or combination product(s) from introduction throughout the lifecycle.

Principally, the Manager, Quality Assurance is responsible for 1) Providing functional oversight and quality support to in-house and CMO teams to ensure consistent implementation of quality concepts across all commercial and developmental programs 2) Monitor changes in national and international regulatory requirements in order to contribute effectively to strategic inputs and regulatory intelligence 3) Ensuring that all activities are in compliance with US, Canadian and EU regulations at all times and 4) Liaising closely with Emergent contractors and material providers.

 

ESSENTIAL FUNCTIONS     
Quality personnel serving at designated site location(s) will be responsible for supporting Combination product design and development, product approval, sustainable manufacturing and supply principally through third-party development and manufacturing partners. The Manager, Quality Assurance role exercises a comprehensive and contemporary understanding of conventional pharmaceutical manufacturing regulations as well as drug device regulations and approval strategies inclusive of ISO/GxP for medical devices / combination products.

The Manager, Quality Assurance role is responsible for all quality systems and the implementation of supportive processes for Emergent combination products (devices). They will ensure internal processes and metrics are aligned to create a high level of product quality and consistency. They will support quality systems having a continuous improvement mindset to achieve business objectives. This role is responsible for supporting the Quality function in an integrated way that supports the delivery of business unit goals.

Quality responsibilities within the scope of this job include the following: 

  • Ensure the site responsible for product manufacturing operates in a manner which is fully compliant with applicable cGMP’s and international standards resulting in minimal audit findings for our Contract Manufacturing Organization(s) (CMO’s) and Contract Research Organizations (CRO’s) from Emergent Auditors, Contract Auditors and Regulatory Agencies.
  • Where problems arise, exercise judgment within broadly defined parameters and policies to identify an appropriate course of action for obtaining results. Erroneous decisions will result in critical delay(s) in schedules and/or may jeopardize specific business activities
  • Promote quality awareness and continuous improvement at the site and across the supplier and CMO network ensuring the proper interface of the site’s quality function for commercial and development product(s) as required.
  • Review of partnerships / relationships with service provider companies and where appropriate, manage the relationship through a formal Technical Agreement.
  • Supervision of and timely close-out of product / process investigations, complaints, deviations, and any other paperwork associated with release of finished product or clinical material. 
  • Maintenance of Quality Assurance Systems, in compliance with appropriate Regulatory requirements (e.g., ISO, FDA, and EU).
  • Build strong relationships with internal and external customers to promote, enhance, and ensure quality awareness.
  • Support the corporate audit team to carry out internal/external audits 
  • Provide QA technical input & assistance in Validation / Qualification activities that EBSI has oversight of, while making sure that all issues and trends are critically evaluated.
  • Review and approve batch release documentation.
  • Ensure timely preparation of and/or management of APQR’s.
  • Manage the EBSI local Vendor Management Program and Change Control system.
  • Ensure all training assigned is carried out per due dates. 
  • Implement and maintain Quality standards for product lifecycle management.
  • Maintain good application of compliance standards to enable excellent relationships with Regulatory agencies.
  • Develop and monitor appropriate metrics to track quality and process improvement.
  • Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals. 
  • Responsible for identifying defects and the reporting of such device combination products defects at any time. 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

.EDUCATION, EXPERIENCE, SKILLS, & PHYSICAL/MENTAL REQUIREMENTS
The ideal candidate will have:
•    BS degree in Engineering, Science, or Operations Management; Advanced Degree (s) preferred.
•    Position requires a Quality Assurance professional with a minimum of 8 years of experience in biotech / pharmaceutical / bio pharmaceutical companies.
•    Experience of medical device (Design History Files) and combination products a distinct advantage.
•    Minimum of three years prior management experience.
•    Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
•    Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
•    Experience in implementation and administration of quality systems for drug Development, manufacturing and quality control operations.
•    Has a thorough understanding of risk management principles and methodologies and their application in Quality Management Systems for Drug Product Combination (devices).
•    Skilled in writing regulatory submissions a distinct advantage.
•    Strong written and oral communication skills.
•    Has a thorough understanding of the regulatory process from IND through commercialization.
•    Certified Lead Auditor.
•    Ability to evolve as project needs change.
•    Strong project management skills.
•    Exceptional interpersonal skills with the ability to negotiate and resolve conflict with poise, tact and diplomacy.
•    Ability to effectively integrate the quality functions into the business.
•    Excellent verbal & written communication skills.

 

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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.