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Senior Supplier Quality Specialist, Dublin ...

Created 14/06/2022
Reference 99905
Category Pharmaceutical
Job type Full Time
Country Ireland
City Dublin
Zip Not specified
Salary Competitive
Senior Supplier Quality Specialist, LEO Pharma Dublin

About us

At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.

Every day, we seek inspiration from people living with plaque psoriasis. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.

As a purpose-driven company, high performance is measured equally as commercial results, brand performance and the positive impact we create - for health care professionals and their patients. These aspirations are encapsulated in our perpetual quest for the world's best talent.

Working in LEO Pharma:

You will be part of a collaborative and innovative community of like-minded specialists, bound by mutual respect; a caring culture; and our deep commitment to advancing biologic treatments mainly for atopic dermatitis and psoriasis worldwide. Driven by dedication, ambition and agility, we apply our extensive dermatology knowledge and focus on long-term results.

About your team:

You will join a highly motivated team - competing with the biggest pharmaceutical brands - inspiring each other with bold new ideas, expertise and knowledge to grow our current size and reputation. At every step of this journey, you will see the impact of your contributions as we grow and transform into a global leader in medical dermatology.

The Role:

As a Permanent Senior Supplier Quality Specialist (P6), based in Dublin, you will be responsible for driving the supplier complaint process and defining any impact on LEO Pharma. This role will be the quality point of contact regarding supplier complaints related to the LEO Pharma manufacturing site(s) impacted.

The role will report directly to the Quality Lead, Dublin but will have a dotted line to the head of External Manufacturing & Supplier Quality (EMSQ).

Key responsibilities would include (but are not limited to):

  • Ensuring urgency and ownership of supplier quality issue resolution in Dublin
  • Single point of contact in local Quality, driving resolution of quality issues together with the supplier. This includes customer complaints and non-conformances.
  • Collaborating with key quality and business partners to ensure full investigation of suppliers' quality issues.
  • Understanding impact of supplier quality issues to stakeholder via go-see GEMBAs on site.
  • Ensuring feedback to stakeholders on Supplier issues.
  • Work with key stakeholders to support supplier quality agreements, support contract creation and sustain supplier relationship building.
  • Communicate and escalate investigation results and facilitate failure investigation decision process.
  • Responsible for ensuring CAPA implementation in LEO based on the information given in the supplier investigation.
  • Participate in periodic Quality management system review and may attend audits at suppliers to verify that process capability requirements are maintained.
  • Supports continuous improvement initiatives for suppliers' complaints,
  • Supports complaint investigation process in internal and external regulatory inspections.
  • Ensures compliance with LEO Pharma QMS and applicable global regulations and requirements regarding complaint investigation.
  • Establish and/or improve monitoring measures for key elements related to Dublin quality goal attainment.
  • Dublin representative in the process group in the Supplier Complaint process.
  • Support EMSQ with local Dublin perspective on supplier performance and taking active part in global supplier performance initiatives.

Qualifications & Key skills you should posses:

Minimum Third Level Qualification in Science (Pharmacy, Chemistry or Engineering) or equivalent.

Minimum 5 years experience in Pharma in a QA/QC environment.

Thorough knowledge of cGMP and relevance regulatory requirements is a must.

Excellent communication skill is a must.

Demonstrated ability to implement continuous improvement methods to improve quality and operations performance. Six Sigma / Lean experience or qualification an advantage.

Thorough understanding of processes within deviation, CAPA, change control etc.

Excellent verbal and written communication skills.

Fluency in English is a must.

Collaborates: A confident team player who can work with a high degree of autonomy.

Decision Quality: Ability to make good and timely decision that keep the organisation moving forward.

Ensures accountability: Holds themselves and others accountable for meeting commitments.

Instills Trust: Gaining the confidence and trust of others through honesty, integrity, and authenticity.

Nimble learner

Situational adaptability: ability to adapt approach and demeanor to match the shifting demands of different situations.

Values differences: Recognizing the value that different perspectives and cultures bring to an organization.

The closing date for all applications is: 27/06/2022

All internal candidates must notify their direct manager if they apply for this role. Failure to do so, will result in you not being considered for this position.