The Director of Quality Systems and Compliance will be tasked with leading the Quality Systems,and Quality Assurance program at our client
- Provide quality assurance leadership, direction and support of corrective action/preventive actions. Support the development and on-going generation of quality metrics.
- Review non-standard issues and develops action plans to rectify situation accordingly.
- Maintain quality systems in support of regulatory and customer requirements.
- Manage the quality assurance incoming inspection process for components according to the company and customer specifications, procedures as well as external standards.
- Manage the batch record process including final quality assurance review and release of finished goods.
- Act as quality and regulatory advisor to President and other executives.
- Manage the documentation change control process including SOPs and internal specifications.
- Reviews, analyzes and develops rationale for recommendations to policy changes to align to business needs.
- Effectively manage department resources, negotiate deliverables and meet commitments.
- Provide leadership, coaching and mentoring to assure a competent, efficient and effective QA organization that works well in cross functional teams. Assure staff is always current with all required training.
- Lead all continuous improvement activities for both product and processes.
Qualifications & Experience:
In addition to the above, we would look for the following specific competencies:
- Experience in manufacturing for OTC and/or cosmetic products.
- High proficiency and knowledge of 21 CFR
- Ability to bring knowledge acquired through previous experiences and adapt and implement strategies catered to our client.
- Experience working with Operations with consolidated goals.
- Experience with Streamlining process to align to business needs.
- Working knowledge of statistical process control tools and methods.
- Highly proficient in use of software and systems including ERP, Access, spreadsheets and other presentation tools.
- Knowledge of the following elements is necessary: inspection and measurement, design control realization, change management, documentation control, validation, project management and regulatory agency (FDA, DEA, ISO, etc.) requirements.
- Track record of accomplishments in quality improvement and successfully satisfying customer (internal or external) expectations.
- Excellent written and oral communication skills that will aid in inspiring team members.
- Capable and comfortable leading training sessions and other formal presentations.
- Good financial acumen and a grasp of income statements, balance sheets, cash flows, and other financial metrics.
- 5-10 years in a pharmaceutical processing environment in a Quality Assurance organization.
- Bachelors degree required; MBA is preferred.
Personal Attributes:
- Strategic Thinker/Sees Big Picture
- Manages Complexity & Ambiguity/Decisive
- Growth-oriented
- Hands on Management Style
- Continuous Improvement Mindset
- Collaborative
- Customer-centric
- Ability to Hire A-players/Develops People
- Adaptable
- Entrepreneurial Mindset
- Operations oriented
Remote Work :
No