Senior Manager, Document Control

Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology’s molecules will quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing the side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes. To learn more about Aktis Oncology, visit www.aktisoncology.com.

The Senior Manager, Document Control & Document Management Systems Administration will be responsible for leadership of each of the two sub-functions within this sector of Quality, as well as individual contribution to establish Quality Systems for Aktis. This role will manage and execute Quality directly related to:

• Document Control
• Computerized Document Management System Administration

These two areas of GXP Compliance support the establishment of clinical phase development (GCP) and commercial manufacturing (GMP) quality systems. Provide Quality leadership and compliance oversight for the application of the designated Document Management System across all GXP operations at Aktis.

The candidate for this role must have prior computerized document management system and change management knowledge. The leader in this role must assure that Technical and Quality documentation controls are effectively in place for all phases of investigational new drugs (investigational medicinal products) to meet all quality requirements, regulatory standards, and continuous clinical supply and delivery expectations leading to commercialization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Quality oversight of computerized data management system (DMS) used within all GXP Aktis operations validation and requalification program and validation master plan.
• Creating and maintaining user accounts and maintaining the Aktis internal & outside contractor DMS Master User List.
• Creating and maintaining system user groups, roles, workflows, and curriculums.
• Coordinating software and potential hardware modifications using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
• Participating in DMS software testing, drafting, and executing validation test scripts.
• Creating and maintaining all operational procedures relevant to the applications and training of Aktis DMS for all departments as necessary with respect to any changes.
• Acting as the Point of Contact for technical support for DMS; ensures accuracy and completeness of data and implements improvements; establishes and maintains security and integrity controls.
• Maintaining familiarity with GMP and GCP best practices and company-specific change control SOPs.
• Interfacing with internal customers for the successful deployment and maintenance of the Document, Training, Quality, and Audit GXP programs.
• Engaging and working with other team members to further configure the system, deploy functional enhancements, and correct configuration issues.
• Providing incident diagnosis and support for business users in the management and timely resolution of technical incidents.
• Provide leadership to supporting staff by directing, mentoring, coaching, and developing them towards professional growth, enhanced job performance, and career satisfaction.
• Provide input for continuous improvement of company quality systems.
• Identify quality issues/discrepancies and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
• Establish, educate, and enforce standard operating procedures required under GXP.
• Maintain a state of readiness for and participate in audits and inspections.

KNOWLEDGE, SKILLS, AND ABILITIES

• Provide Quality Assurance support to all DMS validation activities during the document review to ensure the validation activity is complying with SOPs and regulatory requirements.
• Review and approve Discrepancy, Investigation, Change Control, and CAPA related to the Validation.
• Support internal and external audit programs.
• Strong leadership skills with the ability to thrive in a high throughput environment

PREFERRED EXPERIENCE AND SKILLS

• Provide strong management and leadership skills, including the establishment of clear expectations and the development of metrics and KPIs to monitor performance and ongoing activities.
• Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
• Candidate must possess a strong focus on attention to detail.
• Possess effective task/time management organizational skills.
• Good interpersonal, team, and communication skills are a must.
• Ability to communicate effectively over teleconference and web-based meetings is necessary.
• Strong computer skills include Microsoft Office (Word, Excel, PowerPoint, and MS Project).

EDUCATION AND EXPERIENCE

• BS/BA degree with 6 years of experience
• MS degree with 4 years of experience
• Technology background/experience is a plus
• Quality Assurance background
• Knowledge of GMP, FDA regulations, and compliance
• Ability to help support the implementation of DMS
• Strong knowledge of systems development, life cycle, and systems integration
• Exceptional verbal, written, interpersonal, organizational, and project management skills
• Excellent organizational and project management skills
• Able to lead and mentor junior/senior staff and cross-functional teams
• Strong desire to be part of a mission‐oriented company leading transformative change for patients
• Proven demonstration of transparent communication and fostering open and diverse debate
• Ability to work with agility and manage ambiguity
• Personifies positive energy and exemplifies respect

The position reports directly to the Vice President of Quality Assurance.

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation.