Reports To: Vice President of QA
FLSA Status: Exempt
Department: Regulatory Affairs
General Position Summary
The Associate Director/Director of Quality Assurance, under the direction of the Vice President of Quality Assurance, will oversee all aspects of the Quality Management System (QMS) for InCarda Therapeutics, ensuring systems are in a state of cGXP (GMP, GCP, and GLP) compliance with applicable regulations focusing on medical Quality Systems and Design Controls and are inspection ready.
This position will manage all GXP QA activities for InCarda pharmaceuticals and devices, including but not limited to audits and inspections, batch record review and lot disposition, SOPs and Policies writing, vendor quality management, product complaints, quality events, deviations and CAPAs, Quality Management Reviews, Quality Agreements, generation of quality metric reports, management of DHFs, and support of document control and training programs.
The Associate Director/Director of Quality Assurance will work closely with Product Development, Non- clinical, IT, Regulatory Affairs, Clinical Operations, Clinical Development, GXP consultants, and service vendors and providers.
The Associate Director/Director of QA leads QA Initiatives to improve InCarda Therapeutics standards and systems
The Associate Director/Director of QA provides QA oversight of all GXP activities including but not limited to:
- Managing GXP audits including managing external audit contractors
- Reviewing GXP records such as: batch records, investigations, stability protocols and stability reports, specifications, label proofs and IFUs
- Reviewing and dispositioning GXP products
- Chairing MRB (Material Board Review) and oversee the non-conforming materials program
- Managing Technical and Quality Agreements for GXP vendors
- Overseeing Risk Assessment
- Managing product complaints and returns
- Managing DHF files, Device Design and Purchasing Controls
- Managing regulatory inspection readiness activities
- Providing quality oversite of product dispositions including recalls
- Managing investigations involving study misconduct/fraud
- Managing quality company policies and SOPs and associated training
- Managing Management Reviews
- Reviewing clinical protocols and protocol amendments, investigator’s brochures, clinical service provider management plans, Informed Consent Forms, and clinical study reports.
- This position will support regulatory submissions and on-going regulatory compliance in support of product development.
- Support the preparation of document packages for regulatory submissions, including FDA and EMA submissions, Technical Files, License Applications, and internal supporting documentation.
- Review submissions and audit data as requested.
- Oversee the following quality systems:
- Deviation program
- Document control and record control programs
- GXP employee training programs
- Quality metric reports
Qualifications and Core Competencies
- Understanding and experience in establishing, managing, and maintaining quality systems for pharmaceuticals. Experience with device controls is a plus.
- Highly organized self-starter with attention to detail
- Ability to work independently and manage multiple tasks in a fast-paced environment with minimal infrastructure.
- Excellent written and verbal communication skills.
- Excellent collaborative skills Excellent record-keeping skills
- In-depth knowledge of FDA and EU pharmaceutical regulations and guidance’s.
- Knowledge or experience in risk management.
- Experience with managing vendors and external consultants.
- Excellent negotiation and conflict resolution skills.
Education and Experience
- 8+ years of Quality Assurance experience in pharmaceutical product/medical device development.
- Detailed knowledge of global current GXP pharmaceutical and medical device standards, laws, and regulations.
- Position will require domestic and international travel (~25%)
- Hybrid: In-house and remote is desirable.