Associate Director Quality Systems

Associate Director, Quality Systems (Local Only)

Alladapt Immunotherapeutics, Inc. is a privately held biopharmaceutical company developing pioneering prescription therapeutics for food allergy.  The company’s lead program, ADP101, is being advanced as a broad-spectrum oral immunotherapy treatment for food allergy triggered by single or multiple proteins from an expansive set of common allergens.  We are currently conducting the Harmony Study, a Phase 1/2, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ADP101 for the treatment of food allergy in mono- and multi-allergic children and adults and the Encore Study, an open-label extension study for the Harmony study.  Our approach is based on novel technology licensed from Stanford University based on work from the laboratory of Dr. Kari Nadeau.  Alladapt is led by a team of seasoned biotechnology executives and backed by an expert consortium of investors.  We are driven by an unwavering desire to improve the lives of food allergy patients and their families, and we are guided by an uncompromising commitment to excellent science in the service of that goal.

Description

This is an exceptional opportunity to join a dynamic, fast-paced, innovative, start-up company driven by a very seasoned leadership team. The Associate Director, Quality Systems will be reporting to the Sr. Director, GMP QA.

The ideal candidate will play a key role in the growing Quality team with responsibility for the management of Alladapt’s GxP controlled documents, training program, computer system validation, change control, deviation and CAPA, and document retention.

Essential Functions

• Collaborate with GMP QA Operations, GCP QA, and other functional stakeholders in the development, implementation, management, improvement, and archival/maintenance of Alladapt’s Quality Systems and related infrastructure to ensure compliance with applicable regulations and standards Oversee current Quality Systems to support training, document lifecycle, and records retention for GxP functions Participate in the evaluation, selection, configuration, qualification, and implementation of the Electronic Document Management System (EDMS) and Learning Management System (LMS) to ensure compliance of these systems with regulatory requirements.  Identify and develop procedures for validation.  Act as Business Owner for EDMS and LMS. Provide quality oversight of Alladapt GxP computerized system validation and data integrity program Manage and monitor Alladapt GxP change control, internal deviations and CAPAs Perform periodic review of Quality Systems for potential gaps, overall effectiveness, and opportunity for continuous process improvement Oversee and organize companywide GxP training, including managing GxP curricula, in collaboration with functional management.  Ensure appropriate GxP training requirements/plan are defined for all job roles and training records are current. Support and coordinate internal audits Support and coordinate external audits and regulatory inspections (including mock BIMO and PAI) Coordinate and manage reporting of Quality metrics and overall effectiveness of the Quality Systems for Management Review meeting Lead or execute other projects and initiatives assigned by Management or based on company business needs

Requirements

Qualifications

• Comprehensive working knowledge of cGxP, ICH (E6, Good Clinical Practice; Q9, Quality Risk Management; and Q10, Pharmaceutical Quality System) and other applicable guidelines and regulations (e.g., 21 CFR Parts 11, 210, 211, and 312) Knowledgeable in validation of computerized systems, software, and 21 CFR Part 11 Electronic Records and Electronic Signatures, and EU Annex 11 Demonstrated expertise and relevant prior experience in implementation and validation of QMS and LMS.  Experience with Veeva Vault highly preferred. Experience with writing SOPs, Policies, and Work Instructions Experience in developing and managing investigation, risk, and change management processes Excellent time management skills and the ability to work with a sense of urgency Effectively leads project teams & collaborates cross functionally Ability to build effective relationships with vendors and internal departmental stakeholders

Preferred Education and Experience:

• Bachelor’s degree in a relevant engineering or scientific discipline 8-10 years of hands-on QMS experience in the pharmaceutical or biotechnology industry with significant exposure to implementation, qualification, and management of GxP computerized systems. Experience performing audits and other core Quality System functions. Small company/pre-commercial stage company experience desirable while remaining flexible, proactive, resourceful, and efficient Understand and able to interpret regulatory authority regulations, guidelines, and policies and apply them to Alladapt business activities in a practical fashion

Skills and Abilities:

• Results and goals oriented Excellent verbal, written, interpersonal, organizational, and communication skills are essential with the ability to influence individual and teams across the organization Ability to work independently with minimal guidance Ability to build and manage relationships with business partners

• Excellent cross-functional team collaboration skills Ability to grasp new technologies Ability to work under deadline pressure, and to effectively prioritize and manage multiple projects (multi-task) and rapidly shifting priorities in a very fast-paced environment Strong attention to detail and problem-solving skills

• Ability to prioritize and manage multiple projects to meet critical deadlines