Quality Assurance Manager
About the Role:
This QA Manager will monitor all operations that affect quality in the Company. This role will report to the Vice President of Regulatory and Quality Affairs of EHP and will work closely with the Development and European Operations teams.
The QA Manager is responsible for development, implementation, management and support of applicable elements of a Quality System that will grow with a pharmaceutical company currently in Phase One.
Specific Responsibilities include:
- Develops, evaluates and revises processes/procedures to ensure compliance with GMP/GLP/GCP regulations and guidelines.
- Implements and manages various QMS processes including Document & Records Control, Internal Audits, Supplier Management, Quality Agreements, Training, and CAPA.
- Compiles data for documentation of test procedures and prepares reports.
- Creates, advises on and supports the establishment and continual improvement of Standard Operating Procedures and Work Instructions.
- Develops validation master plans based on FDA/EMA guidance for all processes and methods related to our lead product and follow on products (GMP).
- Provides QA review and approval of production batch records and testing results, specification changes, product non-conformances, deviations and protocols/reports (e.g., validations, qualifications, capability, stability)
- Executes Gap Analysis and/or Risk Assessments
- Develops and manages the change control system including Corrective and Preventive Actions.
- Develops and implements supplier qualification system and oversight program to fully qualify all suppliers, CMO and CRO.
- Provides technical response and expertise during audits, inspections and due diligence.
- Performs the review and validation of the writing of the preclinical part of the regulatory documents (IMPD, IND, IB).
- Assures preclinical studies are performed in accordance with international Good Laboratory Practice (GLP) standards and Company policies & procedures.
- Conducts or monitors audits to review protocol, data, reports and in-lab audits as per GLP requirements.
- Ensures that all processes contributing to the performance of a clinical trials are conducted properly, providing guidance and support to clinical operations and wider organization within Good Clinical Practices (GCP) standards. Devises procedures to inspect and report quality issues.
- Performs and manages training of internal personnel to permit execution of required tasks and ensure compliance to regulatory requirements/Policies/SOPs.
- Supervises and guides inspectors.
- Assures the reliability and consistency of production by checking processes and final output.
- Facilitates proactive solutions by collecting and analyzing quality data.
- Reviews current standards and policies.
- Keeps records of quality reports, statistical reviews and relevant documentation.
- Ensures all legal standards are met.
- Communicates with external quality assurance officers during on-site inspections.
- Maintains up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.
Education, Experience, Skills:
- Bachelor’s Degree in Life/Technical Sciences
- 5+ years of experience in Quality Assurance within a bio-pharmaceutical field, including the following:
- Practice in conducting and/or monitoring audits.
- Experience working with CMOs within the Pharmaceutical industry
- Experience with the development and implementation of current validation systems in the pharmaceutical industry.
- Experience in developing and generating quality system metrics/trending. -Extensive knowledge of Root Cause Analysis / Risk Management / Good Manufacturing Practices / Quality System Regulations and ISO Standards is required.
- Demonstrated working knowledge of international regulations (e.g., FDA, GMP, ICH).
- Demonstrated experience with implementation/improvement of quality systems to ensure efficiency and effectiveness.
- Must possess excellent communication and technical writing skills, with fluency in both written and spoken English.
- Leadership skills with the ability to develop employees and maintain an atmosphere of positive growth and achievement; a self-starter with minimum oversight required to accomplish goals.
- Must be detailed oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. -
- Strong interpersonal skills, and ability to work with others in a positive and collaborative manner; able to communicate with sense of urgency to internal and external customers. Possess a high degree of integrity and accountability.
- Must be able to work as a team member, maintaining day-to-day activities while being responsive to changing priorities.
- Ability to work in an interdisciplinary and international environment. -
- Proficient with PC based office computers and standard Microsoft Office applications.
- Willingness to travel to investigator, vendor, or regulatory agency meetings and audits, as needed.