Director/VP Quality Operations

Discover is working exclusively with a CDMO in the Miami area. They deliver liquid and semi-solid products.

They are looking for sterile injectables/small-volume parenteral experience! They develop and commercialize dietary supplements, OTCs and sterile products. This position is directly responsible for Quality Assurance, Quality Control & Quality Compliance. The Director of Quality is responsible for interaction at the highest levels with regulatory agencies, certifying bodies, management, and critical customers.

The salary for this opportunity starts at 170k with upwards flexibility based on experience. This role also comes with a competitive bonus and it supplies equity.

DUTIES AND RESPONSIBILITIES:

1. Responsible for developing and managing the professional team represented by Quality Assurance, Quality Control & Quality Compliance.

2. Responsible for the identification and resolution of key compliance and quality performance issues relevant to the manufacture and distribution of all products marketed.

3. Set vision and strategy for inspection and audit readiness and provide direction through policy / procedure development and deployment, including training.

4. Responsible for leadership for FDA and regulatory inspections. Represents the company, provides technical support from all resources, guidance during inspections, and interface with inspectors. Responsible for responses to audit observations, and implementation of corrective actions. Coordinates all interactions with and submissions to all healthcare regulatory agencies, and supports related inspections.

5. Tracking of inspection commitments to completion ensuring timelines are met.

6. Provides technical support to Marketing and Customer Service. Organizes customer audits and responses. Coordinates preparation of technical packages required for customer approval of new products, and international submissions for product export. Develops detailed responses to answer complex technical issues from customers.

7. Communicates detailed information on performance of the Quality System and compliance status to management on an ongoing basis through reporting of Quality System Metrics.

8. Responsible for ensuring continuous monitoring of regulations as published, developing comments where appropriate to modify agency proposals in the best interest of the company, and developing plans to meet regulatory requirements economically.

9. Ensures that the company remains abreast of regulatory initiatives, scientific and technological advances, and industry practices in the interest of optimizing product quality and economy. Responsible for representing at FDA and Industry meetings.

SUPPORTIVE FUNCTIONS

In addition to performance of the essential functions, this position may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the manager based upon the particular requirements of the plant:

Participate in continuous improvement projects, troubleshooting, and technology transfer.

Participate in the scientific, technical, and regulatory evaluation of new business opportunities. Assignments may include regulatory due diligence in acquisitions, label claims based on intellectual property, planning for new facilities, etc.

SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities:

Strategic thinking: Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.

Clinical, regulatory and safety expertise: Demonstrated knowledge of clinical research processes, safety and regulatory requirements for cosmetics, dietary supplements, OTC's and Aseptic/Sterile products.

• Technical Expertise: Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.