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.

This is what you will do:

The Manager, Documentation Systems & Services will manage the global Central Quality services team supporting documents and records management, document control, and the business-administration of the Electronic Document Management System (eDMS), Veeva Vault Quality Docs.

Reporting directly to the Associate Director, Documentation Systems & Services, this position will be responsible for: Building, structuring, and managing a cross-global team of contractors and/or full-time employees to support document management services requests, document control coordination requests, Vault Quality (eDMS) and Document Control business process general support, eDMS business-administration (user access management), lab notebook/log-book support and management, records/archiving management, and other projects as needed. As a leader within the Quality organization, the role will be responsible for defining, measuring, and reporting key performance metrics, setting priorities based on business objectives, managing a team or direct-reports, and cultivating a continuous-improvement quality culture.

The Manager, Documentation Systems & Services is a Subject Matter Expert (SME) and primary decision-maker representing Quality processes for Document Management and Vault Quality Docs (eDMS). The role will support integrations, change controls, deviations, CAPAs, and other projects in Central Quality Systems and Services as needed.

You will be responsible for:

• Building, structuring, and managing the global team supporting document coordination, service requests, records management, lab notebook and logbook issuance, eDMS user administration and training, and general Document Management/eDMS support/guidance.
• Establishing and maintaining positive relationships with managed services, contractors, vendors, and suppliers.
• Building strong, collaborative relationships with cross-functional teams to ensure adequate services are being provided and continuously enhanced.
• Managing global processes and training requirements for document changes, creation of new documents, obsoleting documents, records management, periodic review, and Vault Quality business administration/user access.
• Defining, monitoring, and reporting Key Performance Metrics to the Quality Leadership Team (QLT) related to volume, capacity, lead times, and performance in alignment with Central Quality business objectives.
• Effectively planning and defining priorities to team and driving all activities by effectively structuring team, delegating, and overseeing all activities to ensure deadlines, quality standards, and customer-expectations are met.
• Providing leadership and decision-making for customer queries, projects, process-deviations, change controls, and other matters in scope of responsibility.
• Managing direct reports including scheduling, PTO, timecards, performance evaluations, and disciplinary action as needed.
• Setting clear performance expectations for staff and effectively manage team to ensure expectations are being met. This involves supervision, coaching, strong communication, and continuous development.
• Overseeing deviations, CAPAs, and Change Controls in-scope of Documentation Services and continuously monitor process-trends. Providing coaching and oversite on root cause analysis, corrective and preventive actions, and other tasks as needed.
• Cultivating a strong quality culture and continuous improvement mindset across Document Management and Central Quality.
• Managing e-Room used for communication of key documents to CMO’s as required.

You will need to have:

• Bachelor’s degree in Scientific, Engineering, or Business discipline
• 5+ years of experience in a Quality Assurance, Quality Systems, Document Control, Configuration Management, or related role in a GXP-regulated biopharma, medical device, or similar regulated setting.
• 3+ years of leadership experience managing others as a Supervisor, Manager, or demonstrated equivalent.
• 3+ years of experience using GXP validated Enterprise Quality Management Software (Document Management software such as Veeva Vault Quality is preferred) as a Super-User or Administrative level access. Familiarity with system lifecycles, workflows, user profile, security, and data management.
• Demonstrated general knowledge of Quality Management System model for Pharma and/or Medical Devices and general comprehension of the purpose/role of Document Control, Training Administration, CAPA/Deviation/Change Control, Risk Management, Audit/Inspection, etc.
• Demonstrated knowledge and experience using structured problem-solving (DMAIC, Lean, Six Sigma, or equivalent is preferred) in a team setting.
• Experience identifying and driving continuous improvements to processes and procedures.
• Strong understanding of document control, data integrity, good documentation practices, and electronic records compliance for Pharma/Medical Devices.
• Ability to effectively manage in-person and virtual teams. Demonstrated experience coaching, mentoring, and developing others.
• Excellent written and verbal communication skills (English). Ability to build relationships and effectively collaborate cross-functionally and cross-globally.
• Excellent planning and project management skills with the ability to identify priorities and meet deadlines both independently and through others.
• Ability to work in a fast-paced environment overseeing multiple projects
• Strong leadership skills. Ability to assess, problem-solve, and make decisions in a fast-paced environment while considering quality, compliance, and risk.
• 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.

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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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.

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.