Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

The Director of Quality will have responsibility for Quality Operations at the Alexion College Park facility in support of clinical and commercial cGMP operations. The position is responsible for driving cGMP oversight of packaging operational activities on site including new product introductions, equipment qualification, process validation, filing reviews, inspection readiness, site documentation issuance / archival, and QP release of ongoing clinical and commercial product.

This role will establish, manage and support continuous improvement activities of all quality systems to ensure compliance, achievement of site goals / objectives and Inspection readiness.

This position is empowered to be the Quality Signatory on all cGMP documents across the site. The incumbent will organize departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements. The Director of Quality may lead investigations, resolve potential quality issues, recommend and implement changes as necessary.

You will be responsible for:

Ensuring Quality oversight and QP release for commercial and clinical finished products.

Responsible for Lead QP activities.

Ensuring that there is an empowered, effective, and efficient quality organization in place and that it is staffed with competent personnel having the appropriate degree of experience and expertise.

Sustaining employee engagement by creating a culture of inclusion and an environment in which individuals and teams can excel and continuously improve.

Drive governance for Site Quality Management system performance including risk management, deviations, change management, complaint investigations, laboratory investigations and corrective actions. Ensure identification, communication and mitigation of top compliance risks and actively plan to reduce risks at all times. Lead engagement with Quality senior leadership through for Notification to Management process.

Assuring that process and systems are in place to enable operations at site to be performed in a compliant manner, meeting the regulatory requirements defined in relevant product authorisations and health authority requirements.

Actively participate in Quality Management Review (QMR).

Responsible for maintaining Site Licenses and approval of APQRs.

Leading the preparation for and being the site representative for Health Authority inspections.

Representing Quality Operations at various project and technical meetings, as needed.

Developing and maintaining strong and effective relationships with internal Alexion Operations partners across the Alexion network, as well as partners in Product Development and Clinical supply (PDCS), Regulatory Affairs, Human Resources, Legal and Finance leadership to ensure goals are met.

You will need to have:

Degree in biological science or related field.

QP Qualification and time spent operating as a QP required.

7+ years quality management leadership experience in a pharmaceutical cGMP environment.

Extensive knowledge of HPRA, EU, FDA, GMP guidances and regulations.

Demonstrated success leading a Quality organization and partnering with Operations.

Demonstrated ability in decision making, problem solving and project management.

Excellent communication and interpersonal skills

Proven record in demonstrating agility, particularly in support of site activites, including projects and supply requirements.

Flexibility to travel in support of the role.

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

Experience working with aseptic and / or biotechnology products and processes.

Experience working with Finished Product packaging activities.

Experience in successful development, filing and gaining approval for global regulatory submissions

#LI-JB1

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.