Job description
- Work closely with the Quality, Product Stewardship, Business, Operations, and Legal team to ensure compliance with business requirements.
- Help execute and routinely update all corporate cGMP and food safety related strategies, policies, and procedures; maintain open communication with all related departments to address the identification of cGMP and food safety hazards and process improvement opportunities.
- Establish, conduct, and oversee cGMP and Food Safety audits of high-risk suppliers to ensure regulatory compliance and maintain quality standards.
- Work with sites to develop, maintain, and continuously improve standardized policies, operating procedures, work instructions, templates, and other required documents.
- Support effective customer communications with quality statements and agreements. Develop standard documentation to maximum efficiency.
- Collaborate in meeting Quality objectives.
Provide guidance to Site QA Personnel to assure processes are maintained and validated within controlled operating parameters.
Ability to travel up to 30% globally.
- 4-year B.S. degree in Chemical Engineering, Chemistry, or Life Science (Other degrees will be considered)
- 3+ years of relevant cGMP and/or FDA experience in a manufacturing environment
- Good communication skills
- Must be a capable leader, able to influence the organization from the shop floor to senior leaders.
- Must be able to build relationships with various functional and business leaders to drive change in their areas.
- Self-motivated with an ability to make independent and informed decisions
- Extensive knowledge and practical experience with Quality Systems to include ISO 9001, cGMP and HACCP
- Knowledge of European and US regulations applicable to food, pharmaceutical and cosmetic products
- Medical, Dental, Vision Insurance
- Life Insurance and Disability
- Grace Wellness Program
- Flexible Workplace
- Retirement Plans
- 401(k) Company Match – Dollar to dollar up to the first 6%
- Paid Vacation and Holidays
- Parental Leave (salaried only)
- Tuition Reimbursement
- Company Donation Match Program
- U.S. Employee Benefits Summary (grace.com)