Senior Specialist, Clinical QC Compliance, Analytical Development and QC at Alexion in New Haven, Connecticut

Job Description:

This is what you will do:



ADQC Senior Compliance Specialist is responsible for maintaining the highest standard of quality and compliance in ADQC and the Clinical QC (GMP) laboratories. This candidate will be responsible for initiation and ownership of change controls relevant to ADQC biologic and gene therapy programs as well as strong liaison with IT for involvement, collaboration, coordination and oversight of the Clinical QC periodic review process and oversight for workstations and computerized systems.


Additionally, it is expected that this candidate will by identifying quality requirements, disseminating policies, procedures, conducting internal audits, recommending improvement plans and performing relevant assigned compliance tasks.



You will be responsible for:

• Responsible for generating, reviewing, providing assessments and driving ownership of Change Controls for Analytical Development and Quality Control (ADQC).


• Lead role in ADQC and collaboration with IT for validated systems: Drive process for periodic reviews to ensure compliance with regulatory standards, maintain data integrity, and optimize system performance


• Track and present schedules for compliance related events in ADQC (Periodic reviews, system qualification and validation activities, guidance document updates, system obsolescence and upgrade need etc.)


• Generate and/or review equipment and system validation protocols/reports etc.


• Strong compliance involvement for laboratory investigation reports, deviation reports, CAPAs


• Provide key assistance in Quality audits for area of expertise and design corrective/preventative actions to observations


• Conducts reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements


• Identifies opportunities for improvement in systems and makes recommendations for effective changes to ensure compliance with cGMP


• Assist compliance team with equipment maintenance and management as needed.


• Strong presentation skills


• Create plans and present timelines to meet established targets, goals and objectives

You will need to have:

• A successful candidate will have a minimum of BS/BA degree in a relevant field with 5+ years of experience working in cGMP setting


• A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.


• Working knowledge of computer software validation and guidance documents/regulations (e.g., 21CFR part 11, GAMP 5, ICH Q7, Annex 11)


• Strong working knowledge of Microsoft suite programs


• Effectively organize and manage work responsibilities. Excellent time and project management skills with the ability to multi-task.


• Strong proficiency in quality management systems and audit procedures.


• Strong and effective communication skills for interacting with cross-functional teams and regulatory authorities.


• Mental Acuity: High attention to detail and ability to maintain accuracy in documentation and processes. Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.


• Physical Requirements: Ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances

We would prefer for you to have:

• Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.


• Knowledge of pharmaceutical/biotechnology manufacturing process


• Database management and statistical analysis (e.g., JMP, Tableau, SAS)

Date Posted

25-Feb-2025



Closing Date

24-Apr-2025Alexion 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. Apply Now