Reports To: SVP Regulatory
FLSA Status: Exempt
About the Position
The VP, Quality, under the direction of the Sr. VP of Regulatory Affairs, will oversee and maintain InCarda’s Quality Systems and provide sound technical support and advice on quality assurance matters.
The VP will be responsible for the leadership, management and execution of Quality activities to ensure compliance with current Good Clinical Practices (GCP), Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLP) and other applicable worldwide regulations.
The VP is also responsible for providing assessments to Senior Management as to the compliance status of the company, and for the direction of policies and procedures in alignment with global regulatory expectations. This position will be responsible for the internal/external audits and preparing the company for GxP inspection readiness.
Additional responsibilities include supporting the development of adequate capability and capacity in the Quality area to support company goals. The VP will also identify needs, contingencies and operational plans, while also ensuring strategic positioning with company goals.
- Act as Management Representative for the company, if it is required.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal/external policies and procedures to assure effective GxP compliance.
- Ensure InCarda processes and procedures in
- Clinical (Clinical Development, Clinical Operations),
- Biometrics (Statistics, Programming, Data Management),
- Pharmacovigilance/ Drug Safety, and
- Medical Affairs comply with GCP and GLP as well as other applicable regulations (for instance, GDPR)
- Lead the overall direction, processes, systems and personnel development for the Quality organization.
- Perform gap analysis to identify potential deficiencies and assess compliance periodically.
- Develop and maintain the Quality Manual. Ensure compliance in the following GMP areas:
- Management Review and Continuous Improvement
- Document and Data Control
- Training Program
- Purchasing Controls, supplier selection, qualification, quality agreements
- Audits and Inspections
- Risk Assessment and Management
- Design Controls, Product Development and Manufacturing
- Non-Conformances, CAPA
- Complaints / Returns
- Product Labeling
- Product Recall
- Statistical techniques
- Validation/Manufacturing/Release: The VP is responsible for the review and disposition process for cGMP lots, including:
- Oversee generation and review of documents used in GMP activities
- Oversee the development of procedures for the review and approval of executed manufacturing production records and testing documentation for cGMP lots intended for clinical and stability study use.
- Ensure all documentation from manufacturing, packaging, labeling, inspection and laboratory control records, including all discrepancy reports is considered to determine compliance with established procedures, specifications and applicable regulatory requirements prior to release of a batch or stability information.
- Support Regulatory submissions and on-going regulatory compliance in support of all stages of product development.
- Plan, coordinate and prepare document packages for regulatory submissions, including FDA and EMA submissions, Technical Files, License Applications, and internal supporting documentation.
- Review and approve submissions.
- Oversee and manage all internal and external GXP audits and prepare company for inspections to support licensing applications.
- Provide technical guidance and training / mentoring to other QA employees and cross-functional teams.
- Develop and implement departmental policies and procedures.
- Education in scientific discipline preferred
- Direct experience with creating and managing GxP systems in support of all stages of product development for pharmaceuticals through licensure is required.
- Experience with global GxP systems is preferred.
- Detailed Knowledge of FDA and EMA pharmaceutical and medical device regulations, guidances, and import/exports requirements.
- An in depth understanding of GCP regulations and familiarity with industry standards pertaining to clinical quality assurance.
- Thorough knowledge of the pharmaceutical product development process, and medical device design controls.
- 12+ years of Quality Assurance experience in pharmaceutical product/medical device development and manufacturing.
- Knowledge or experience in risk management.
- Ability to manage vendors and external consultants. Excellent negotiation and conflict resolution skills.
- Statistical analysis ability preferred.
- Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
- Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
- Strong personal presence with ability to command respect through exercise of sound business judgment and clear decision-making.
- Position will require domestic and international travel (~25%).
InCarda Therapeutics, Inc. is a leading clinical-stage biotechnology company located in Newark, CA. InCarda’s unique technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of therapies for managing atrial fibrillation and other related conditions with unmet medical need. InCarda was founded in 2009 and has developed a best-in-class platform with a leading intellectual property position.