Role posted on: 20th March 2019
G&L are a specialist provider to the healthcare industry for all types of Quality and Regulatory Affairs consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.
We now have multiple opportunities in our global Quality team, where you could be joining our international team of experienced professionals who manage multiple global projects for a wide variety of clients – from giant pharma to niche biotechs. A day in the life of one of our consultants can be varied and unpredictable – this opportunity would be perfect for someone who thrives when busy, enjoys guiding clients through complex regulatory strategies and is completely solutions-orientated.
Role Description: Quality Manager, Ontario, Canada
- Responsible for identifying compliance risks, proposing solutions and ensure adherence to current GxPs, G&L Guidelines and industry standards.
- Role has a vital contribution to the management of the quality system, company compliance and will routinely interface with Regulatory Authorities and corporate/third party auditors; activities must be appropriately developed and executed
- Responsible for managing the CAPA system and lifecycle for regulatory inspections and audits, including finding responses and associated corrective actions; interaction with various levels of the organization both locally and globally required.
- Decisions can establish or influence policies or procedures that affect business plans, departments and resources; errors can have significant consequences in terms of compliance and company image
- Industrial environment will require incumbent to follow routine medical surveillance requirements
- This position requires a strong understanding of applicable GxPs, as relates to quality assurance in manufacturing, packaging, storage, testing and distribution of pharmaceutical products, as well as current industry standards; this is critical to supporting inspections/audits and ensuring appropriate development of CAPAs stemming from inspections/audits and deviations, as well as for process improvement.
- Incumbent must be effective in working collaboratively with a variety of personnel/experts from all internal GxP-related departments and other quality functions (both locally and ), as well as possess a high level of organization at both individual and team levels; these aspects are critical to ensuring smooth inspection life cycle and quality system management.
- Strong verbal and written communication and technical writing skills are needed in order to prepare accurate, clear and comprehensive documents/communications.
- Incumbent will be required to interact with a broad spectrum of personnel, including external regulatory bodies, corporate and third party auditors, therefore also drawing on all of the above skills/knowledge.
Education and Experience:
- Bachelor of Science Degree, specializing in the pharmaceutical sciences
- At least 6 to 8 years of pharmaceutical experience within a Quality role (Quality Assurance, Quality System Management and/or Inspection Management); additional auditing experience an asset.
- Strong technical writing and communication skills;
- Excellent knowledge of international GxPs.
Key Technical Competencies:
- Experience with the management of Quality Systems.
- Ability to communicate and work with a very broad spectrum of professional and technical staff.
- Knowledge and competencies in project management principles.
- Good problem-solving skills.
- Excellent GMP knowledge and ability to transfer knowledge.
Your daily workload will be fluid and completely responsive to our clients’ requests – and no project is the same. We need someone who is an excellent communicator, a selfless team player, a brilliant multitasker – but most of all, someone who has a good sense of humour! We want to enjoy our work, have a happy office and consistently deliver exceptional services to our customers – so we are only recruiting people with a can-do, why-not, positive attitude.
If you would like to hear more, please send your details to firstname.lastname@example.org today!
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.