The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining quality systems supporting the organization’s products and/or development processes.
The QA Manager will initially work under the direction of the current QA Director, who is a consultant to Acumen. The QA Manager will assume responsibilities for the management of QA activities over time, and Acumen’s intention is that the QA Manager will be a leadership track position.
The QA Manager will work closely with peers in CMC, Clinical, Non-clinical, Non-clinical, Project Management and Research functions and will be jointly responsible for effective QA support of cross-functional activities.
Travel within the US will be required. Travel outside of the US may be required in the future.
Location: Carmel, IN with potential to work remote during 2021. (relocation possible for qualified candidates)
ROLE AND RESPONSIBILITIES:
Role: The Manager of Quality Assurance (QA) is responsible for working with the current QA Consultant Director in providing quality oversight for product manufacturing activities including review of executed batch records, batch release and change control processes associated with manufacturing activities, as well as for implementing and monitoring the effectiveness of Quality Systems throughout our organization. The QA Manager should possess a working understanding of cGMP requirements as well as ICH, FDA and other relevant pharmaceutical industry regulatory guidelines. The Manager of QA will also be involved in investigations related to drug substance/product manufacturing activities, product complaints and ensures closure in a timely manner. The individual in this role will report to the Chief Operating Officer but be provided specific position direction from the current QA Consultant Director. This individual is expected to excel at working in a collaborative cross-functional environment with team members from manufacturing (CMC), analytical development, Clinical, regulatory, and contract manufacturing organizations (CMOs) and other service providers.
- Provide support in quality oversight for drug substance/product manufacturing activities including review of executed batch records and subsequent batch release/disposition.
- Develops and maintains a phase-appropriate Quality Management System
- Identifies and establishes appropriate quality standards, specifications and parameters for products.
- Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.
- Assist in ensuring investigations related to deviations during drug substance and product manufacturing are completed appropriately and in a timely manner.
- Interface with manufacturing, analytical development, clinical, nonclinical, and regulatory team members regarding change controls, protocols, quality requirements, and reports.
- Write and revise standard operating procedures for the Company, as necessary.
- Support document control functions, including initiating, tracking, processing, reviewing, distributing, releasing and archiving of documents.
- Identifies and investigates non-compliances, particularly when problems recur in multiple products; recommends and facilitates corrective and preventive actions.
- Reviews client, customer, and user feedback and takes appropriate action, as needed.
- Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.
- Prepare and/or support the preparation and review of Quality Agreements with CMOs.
- Perform and support audits of CMOs and CROs and other GxP vendors.
- Support the collections and evaluation of metrics to measure the health and effectiveness of the quality system that promote the identification and implementation of quality system improvements.
- Support FDA and other health authority GMP inspections or Sponsor Audits, including assisting in pre-approval inspection activities (preparation, conduct, and responses).
- Perform other assigned tasks as needed.
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
- Three to five years of experience in GMP related field required with supervisory experience a plus working knowledge and understanding of GxPs for drugs in development.
- Understanding of standards of practice for the manufacture of monoclonal antibodies is a plus.
- Ability to maintain attention to detail, prioritize work and handle multiple assignments in a fast-paced environment.
- Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.
- Ability to adapt the work schedule to participate in teleconferences with CMOs in different time zones.
- Must have excellent verbal, written and organizational skills.
- Must have excellent leadership and interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
COMPENSATION AND BENEFITS:
Competitive base salary, annual incentive bonus and company stock options. Package details based on qualifications and track record of performance.
Competitive benefits package including health, dental, vision, life insurance and 401K.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals, Inc., is a privately held company with offices in Charlottesville, VA and Carmel, IN. Acumen is developing targeted therapies for the safe and effective treatment of Alzheimer’s Disease and related neurodegenerative diseases. Acumen’s lead program, ACU193, is a monoclonal antibody which binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer’s Disease pathology. Acumen plans to initiate human clinical studies of ACU193 in 2021 and is seeking to add key contributors to support the development of ACU193 and the growth of the company.
Acumen Pharmaceuticals, Inc., is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Acumen prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Acumen conforms to the spirit as well as to the letter of all applicable laws and regulations.