|| Director, Compliance & Quality Systems
The Director, Compliance and Quality Systems will have the responsibility for managing and leading functions that include but are not limited to investigations, training, internal auditing, quality oversight of validation (process and computer), metrics and quality council primarily for Frontida PA and for Frontida Aurora where processes are shared across sites.
Responsible for leading the compliance processes and quality systems including investigations, training, internal auditing, quality oversight of validation (process and computer), and metrics reporting. Ensure these processes are designed and executed according to cGMP, company SOPs and applicable regulations.
- Collect metrics across the company for trending of quality performance, identification of trends and improvement opportunities
- Lead the quality council management review meetings by presenting metrics, quality initiatives and driving quality improvement across the organization
- Manage direct reports and team, drive a high performing organization, develop personnel for current and future roles within Frontida
- Provide Quality support for electronic system integration
- Collaborate across sites to develop common processes and procedures where applicable
- Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business needs
|Knowledge and Skills
- Bachelor’s degree in in a related discipline with 10-15 years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
- Experience leading teams to improved performance demonstrated through metrics
- Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
- Experience with quality systems, investigation writing, CAPA, preferred
- Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, preferred.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- High degree of professionalism, ethics and integrity
- Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
- Willing to participate in our group identity characterized by commitment, trust, and care for each other.
- Willing to invest time and energy in continuous improvement efforts