Alexion Pharmaceuticals Sr. Director, External Quality CMO & CLO in Ireland
The Senior Director of External Quality sets the strategic direction for the contract manufacturing quality organisation. This includes managing and directing the operational quality oversight of global biotech Drug Substance, Drug Product and Finished Product contract manufacturing site(s) (CMOs) throughout the product lifecycle.The role is the Quality representative on the CMO Leadership team which recommends selection of CMOs and with thei rteam manages the day today Quality interface with CMOs.
Set strategic direction for CMO quality organisation.
Owns the CMO Quality Risk Management process and metrics reporting as a result of this process. Drives "top risks" identification at each CMO. Drives quality improvement with partners.
Manages and directs team to execute quality oversight of contract manufacturing organizations, including systems and processes pertaining to risk management, change implementation, deviation/investigation review, CAPA and batch release.
Ensures the delivery of product to the required specification for Alexion.
Manages team that dispositions producUperforms QP release for CMO manufactured product.
Manages the relationship between CMO Quality and Alexion Quality.
Negotiates and oversees Quality Agreements between CMO and Alexion.
Ensure External Quality team verifies the GMP readiness of CMOs, support Alexion inspection readiness activities and participate in CMO health authority inspections including interaction with inspectors, responses to inspection observations and to monitor progress of follow up actions to closure.
Minimum 15 years' experience in the pharmaceutical industry with at least 5 years in a leadership capacity.
Minimum 5 years' experience of biotechnological drug substance manufacturing and drug product aseptic manufacturing operations with minimum 3 years' experience managing CMO relationships in the biopharmaceutical industry.
Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements verification, and quality management systems.
Ability to operate efficiently in a complex matrix organization and international environment.
Ability to deal with external parties towards delivery of agreed requirements.
Management skills for the development of a team of quality experts.
Strong mature leadership and interpersonal influencing skills.
Ability to represent the company and to negotiate at different levels both internally and externally.
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
Bachelor's degree in science, pharmacy, engineering or equivalent required; advanced degree a plus.
Eligible to act as a Qualified Person as per EU Directive 2001/83/EC.
- Ten or more years of experience in the pharmaceutical industry required with five or more years in a leadership role.
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. As the global leader in complement biology, Alexion developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). In addition, Alexion has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Our research efforts focus on novel molecules and targets in the complement cascade, and our development efforts focus on our core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team.