Associate Director/Director Quality Assurance Operations

Description

Title: Associate Director/Director Quality Assurance Operations

Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.

Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier? 

To learn more, visit marengotx.com.

Role: Associate Director/Director Quality Assurance Operations

Overview: The individual in this position will provide end-to-end phase-appropriate product quality, compliance management, and vendor oversight and management.

Please: local candidates only. This is a full-time, in-the-office role.

Who are we looking for? 

· You are an energetic and passionate Quality professional who likes to think outside of the box, challenge the norm, and is passionate about the company’s mission of discovering and developing new medications

· You are a resourceful self-starter and team player with a strong results orientation

· You consider yourself a guru in all the critical Quality clinical stage organization areas

· You can develop collaborative relationships to gain support and achieve results at all levels of the organization

What are we looking for?

· A driven professional who knows how to work and contribute to an ever-changing working environment

· A collegial individual who enjoys working in close collaboration with leaders in the research, development, manufacturing, quality, clinical, and administrative areas of the company

· A willingness to learn new things, adapt to new ways, and go with the flow

· A person who thrives in a small company atmosphere

· Ability to determine risk, identify appropriate solutions and deliver product-quality tasks

What are we offering?

· Membership within a growing, CARING, and collegial organization

· Being part of a passionate, collaborative, and  involved Quality organization

· Exposure to pioneering science and the discovery of drugs to help treat patients

Responsibilities: 

· Establish and Maintain Appropriate Development Phase GMP/GLP Compliance for Material/Product Development, Manufacture, Testing and Stability

· Establishment and Approval of Material Specifications, COA, and COC

· Material/Product Disposition Activities

· Review and Approval of Testing Documents, Including Method Validation Protocols, Reports, and Raw Data

· Oversight and Management of the Material Stability Program and Material Shelf Life.

· Vendor Qualification, Management, and Oversight

· Providing Quality Guidance and being Accountable for the Continuous Development, Execution, and Administration of the Phase Appropriate Quality Systems. Including Resolution of Quality Issues.

· Provide Support for Regulatory Filings, Including IND, BLA, and Regulatory Updates

· Continuous Improvement Activities

Requirements

 Education and Experience:

· Minimum of 10 years of progressive, relevant experience in the biopharma or medical device industry required

· Bachelor of Science is required; MBA/advanced degree welcomed.

· Minimum 8 years of progressive, relevant experience in the biopharma or pharmaceutical industry required. Experience in a GMP Quality function at a Biotechnology or pharmaceutical organization. 

· Candidate should have 4 years’ experience in QA Operations/Material Disposition role.

· In-depth understanding of quality principles and GMP/ICH/FDA/EU regulations presented by the global health authorities.

· Good interpersonal skills and ability to work collaboratively and cross-functionally.

· Vendor qualification and audit experience.

· Experience with managing and overseeing vendors related to manufacturing, testing, label/pack, and distribution.

· Ability to complete risk assessment and resolve product quality issues.

· Experience with working with development and clinical phase material/product.

· Technical knowledge of analytical method qualification and establishment of product specifications.

· Excellent analytical skills and ability to gather information, perform risk analysis, and communicate issues in a simple way.

Competencies:

Planning: Creates a work plan defining deliverables, milestones, accountabilities, and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests, and due dates. Allocates appropriate amounts of time for completing your own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions, plans, and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. Ability to take direction.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly, escalates in a timely manner and drives changes necessary to achieve business objectives

Location: Cambridge, MA ( We are located in Lower Cambridge, called Cambridgeport)

When You Join Marengo, You Will Have:

In addition to the compensation, we offer the following benefits:

• Free parking, Cambridge location reachable by public transportation (Red Line)

• Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision

• Flexible Spending Accounts for medical and dependent care expenses

• Eligible from the first day for 401K, no matching

• A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability, and parental leave

• 20 days of vacation and one personal day, and 64 hours of sick time per year, in addition to 16 company holidays

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.

Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.