Quality Release Manager
Quality Release Manager
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.
As a Quality Release Manager (M6) you will be responsible for managing, developing maintaining and implementing all quality release activity for Dublin. You will act as the Site Principal QP and manage the organizational development of the Dublin QP team providing proactive leadership for the Quality Release department. You will report to the Quality Director and will be an active member of the Dublin Quality Leadership team.
Key responsibilities would include (but are not limited to):
· You will manage quality batch documentation, reviewing and archiving.
· You will be responsible for all product release management including deviation approvals.
· Working with the Quality Operations Dublin and Senior Managers, managing any product recalls.
· Manage and support product stability OOS/OOT data investigations.
· Manage and support the annual quality product review.
· Ensure all associated Standard Operating Procedures (SOPs) and Work Instructions (WIs) are in place, reviewed, updated and that they are read and understood by departments.
· Provide aligned QP Support for operational production and laboratory areas.
· Provide process change control support.
· Promote a continuous improvement mindset and provide input and support to system, process improvements/projects.
· Provide department input to process or product investigations.
· Provide input and support to quality audits/inspections.
· Provide quality batch /declaration information as requested and provide QP participation in Module III process.
· You will drive, develop, implement and maintain GMP standards for the operational production departments to ensure regulatory compliance.
· You will drive strong people management making sure to support, develop, coach and engage a team of QPs.
· The Quality Release Manager is a key member of the Dublin Extended Leadership team.
Qualifications & Key skills you should posses:
· Minimum of B.Sc Degree or equivalent third level qualification under EC directives as a Qualified person
· At least 3 years experience in a quality or production function in the pharmaceutical industry.
· Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
· Supervisory experience, demonstrated strong change management skills & excellent people management and stakeholder management skills.
· Solid understanding of LEAN, planning & standardisation.
· Be innovative, by creating new & better ways for the organisation to be successful.
· Have a strategic mindset, seeing ahead to future possibilities & translating them into breakthrough strategies.
· Self-starter with ability to complete work independently as well as successfully lead others if needed.
· A “can do” attitude and genuine enthusiasm for driving improvements
· A positive mindset of Safety First
Our Core Competencies & Behaviors:
· Courage: Stepping up to address difficult issues, saying what needs to be said.
· Develops Talent: Developing people to meet both their career objectives and the organization’s goals.
· Drives Engagement: Creating a climate where people are motivated to do their best to help the organization achieve its objectives
· Builds Effective teams: Building strong-identity teams that apply their diverse skills and perspectives to achieve common goals.
· 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.
· 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: 23/05/2022
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.