QA Manager & Deputy RP ( Quality Distribution)

We are seeking applications for an experienced QA Manager/Deputy RP for our client, who are a leading biopharmaceutical company
In this role you will manage the Quality Distribution Operations team and support the Responsible Persons and equivalent country quality managers in distribution related quality management systems. You will also act as QA technical contact point with Country Quality Managers & affiliates, own GDP processes and procedures applicable to multiple entities/markets.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• Lead the Distribution Quality Operations team to:


• Oversee Quality Distribution operations for the supply & distribution of product to global markets.


• Provide line management support for a team of Quality Specialists/ Snr. Specialists.


• Own GDP processes and procedures applicable to multiple entities/markets. Collaborating with RPs and equivalent Country Quality Managers, drive continuous improvement and harmonization/optimization of processes / procedures. 


• Define and monitor standard quality KPI and review quality indicators with recommendation for actions for improvement. Attend and support the development of material for Quality Distribution related Quality Management Review meetings


• Develop and enhance training materials related to GDP as needed.             


• Collaborate with appropriate RP and Country Quality Managers to provide quality oversight for cold chain validation activities.


• Act as QA technical contact point with Country Quality Managers at affiliates. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.


• Collaborate with APIOUC (Ireland) Responsible Person, review documentation including but not limited to Quality Agreements, change controls, deviations, returns, validation documentation, SOPs and specifications.


• Providing Quality oversight for GxP Vendors including 3PL warehouses, logistics partners & other service providers.


• Oversee the Distribution QA release of batches at distribution centres for onward supply.


• Provide Quality oversight for Distribution complaints (SCARs) with 3PL warehouse and logistics providers.


• Provide Quality Distribution support for global product launches.


• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.


• Support APIOUC (Ireland) Responsible Person to ensure compliance with the general conditions of the Company Wholesale Distribution Licence and ensure compliance with the requirements of GDP, including but not limited to acting as deputy RP, as required.


• Support work streams relating to market monitoring and investigations relating to the Falsified Medicines Directive.


• Support audits of contractors executed according to company external audit program


• Project Management of Key Project Schedules across the network.


• Demonstrates core Values through management style


• Any other duties as required by management.

What you need to apply:

• Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility


• Minimum 5 years of experience in Quality Assurance and Good Distribution Practices.


• Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements


• Thorough knowledge of local GDP and global regulatory requirements


• Deputy RP experience is preferred.


• Demonstrated success records in improvement processes


• Ability to operate efficiently in a complex matrix organization and international environment

If a Quality Assurance Specialist sounds like the job you'd be perfect for, we'd love to hear from you! As it happens, we are currently actively seeking candidates to fill this job. You’ll be looking after the delivery of quality assurance activities in Dublin location to making sure new products are introduced and manufactured in accordance with cGMP, corporate and regulatory requirements. The Quality Assurance Specialist delivers in order to protect the safety, quality and efficacy of products for our patients as well as assuring the security of the company’s business and global markets.  You will be part of a dynamic team and working across other departments, locations and partnering with major stakeholders.
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.


• Excellent career progression opportunities.

 
What you will bedoing:

• Overseeing new product introduction


• Giving technical guidance for all QA and compliance topics. 


• Reviewing and approving project documents


• Collaborating cross-functionally.


• Reviewing and approving of validation documents for equipment, software and equipment qualifications, and others.


• Complying with current regulatory expectations, EU, FDA and corporate standards.


• Managing quality on operations and technical services


• Reviewing and signing off on process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents.


• Evaluating and accepting new requests related to new products.


• Making sure materials are sampled and released appropriately.


• Examination and approval of deviations made during qualification/validation testing.


• Taking part in the project change control program.


• Giving guidance on quality regulations for validation strategy.


• Timely reviewing of documentation/investigations/reports highlighting


• Helping in the resolution of issues commensurate with the level of risk


• Making sure that schedules for review and approval of GMP documents are maintained to meet the needs of internal groups.


• Giving support to internal departments e.g., engineering, utilities and supply chain


• Helping with deviation investigations


• Energetically helping support audit readiness activities and regulatory agency and internal audits.

 
What you need to apply:

• Batchelor’s of Science in Science or Pharmacy


• 3+ years’ experience in cGMP Quality environment; or equivalent combination of education and experience.


• 3+ years relevant experience within the pharma industry or a related field.


• Excellent knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.


• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes is strongly desirable.


• Past experience of GMP management within a pharma/biopharma company is essential.


• Experience working to FDA, HPRA/EMA or other authorities of similar standing. 


• Excellent attention to detail


• Good knowledge of relevant computer packages e.g., TrackWise or similar


• Strong project management skills.


• Great technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.


• Strong technical writing skills.


• Brilliant interpersonal skills.


• Excellent communication skills, verbally and written.