The Quality Assurance Manager has a primary role in assuring that products manufactured at the Athlone site are done so in accordance with cGMPs and pertinent corporate and regulatory requirements. He/she will also support the introduction and expansion of new drug product platforms across the site. He/she will support operational readiness activities in preparation of product launches. The QA Manager reports to the sites Quality Director.
Essential Duties, Functions and Responsibilities:
The Ireland manufacturing plant is scheduled to be built out, commissioned and validated over an approximate 3-year period. The Quality Assurance Manager will provide key input on the plant specifications and requirements and will help lead QA work during the start-up phase and into sustained operations.
Provide quality expertise to the site
Ensure operations are in compliance with cGMP
Manage QA team through QA Specialists to provide quality and compliance support for the site
Ensure Qualified Person support for site and global batch release
Provide required metrics and support for internal and supplier management audits
Effective interaction with other departments on matters related to investigations and finished batch releases. In particular, close contact maintained with the QC, Manufacturing, Engineering and Supply Chain.
GMP Document Review
Internal and Supplier Management Audits
Regulatory and Corporate audit support
Quality System compliance and improvements
Operational compliance metrics
Leader with excellent manufacturing experience and knowledge across multiple platforms.
Direct experience of (including leadership) of product technical transfer.
Strong QA and Regulatory understanding. Direct regulatory audit experience.
Strong communication and interpersonal skills.
Strong manufacturing/technical leadership skills.
Excellent process understanding of the various stages of sterile manufacturing through to inspection and packaging.
Knowledge of project management fundamentals.
Excellent working knowledge of risk based validation philosophies, Design of Experiments (DOE) and root cause analysis.
Operational experience of quality systems in a dynamic manufacturing environment.
Ability to lead/provide input into technical investigations
Technical knowledge of sterile manufacturing and pharmaceutical plants
Understanding of Quality Management Systems and cGMP for US and EU
Able to manage projects to plan/budget
Good communication skills at organisation, team and individual levels
Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)
Post-graduate studies as appropriate to augment primary degree
Qualified Person status desirable.
5 -7 years experience working in the pharmaceutical sector including sterile manufacturing with experience of Ophthalmic Products desirable..
3 - 5 years experience in management of QA
Project Management Experience
Hosting of Regulatory and Corporate Inspections
Personal Characteristics Required:
Excellent communication skills (interpersonal, presentation & writing)
Ability to effectively communicate technical & non-technical information
Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment
Initiative able to work in a self-directed manner to see issues through to completion
Highly motivated. Ability to multi-task
Ensure compliance to cGMP at all times
Natural influencer and works well as part of a multi-functional team
Highly motivated and self-resilient
Adaptable and flexible as well as a pragmatically minded problem solver
Energetic in the pursuit of improved processes and ultimately improved performance
Focussed on development of direct reports
Work Environment/Hazards and Physical Demands:
The physical demands include those required of a normal office position and engineering shop floor support in a cleanroom environment. While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear. The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg. The employee is occasionally required to crouch. The employee is occasionally required to climb ladders to access technical areas. The employee must be capable of wearing sterile cleanroom garb in a grade B environment. The employee must be capable of wearing protective and/or safety equipment as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time. However during the initial start-up phase of the manufacturing facility project, this may be as high as 30-50% for the first 12 months.