Global Compliance Manager

Grace is seeking a Global Compliance Manager, MT to join our Environmental Health & Safety team as we grow and develop our organization to build a scalable platform for rapid organic and inorganic growth. This role is located in Columbia, MD.

The Global Compliance Manager, MT is responsible for promoting and supporting a culture of quality, compliance, and safety for the Food and Pharmaceutical segments within Grace's Materials Technologies (MT) Business Unit. This role will coordinate quality compliance activities for regulated materials sold into the Food, Pharmaceutical and consumer markets. MT products are used throughout the food and pharmaceutical supply chains as, for example, food additives and processing aids, excipients, dietary ingredients, and active pharmaceutical ingredients, including as a custom manufacturing organization. Deep understanding of and experience with implementing food and/or pharmaceutical current Good Manufacturing Practice (cGMPs) is essential.

* Corporate oversight of pharmaceutical ingredient manufacturing Quality Unit.
* Work closely with the Quality, Operations, and Legal team to ensure compliance with regulatory requirements including global registrations and regulatory strategies.
* Act as a corporate cGMP Subject Matter Expert for change management system.
* 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 cGMP sites to develop, maintain, and continuously improve standardized policies, operating procedures, work instructions, templates, and other required documents.
* Conduct both process and analytical validations in support of site level GMPs and define and manage a global master validation plan (MVP). Perform required preventive controls monitoring.
* Support effective customer communications with quality statements and agreements. Develop standard documentation to maximum efficiency.
* Manage product recalls and withdrawals, including timely communication with customers and regulatory authorities, as needed, including completion of related documentation.
* Knowledge of EU, USP, ICH, FSMA (preferred), IPEC (preferred)
* Serve as the Corporate SME for cGMP, FDA and internationally regulated materials.
* In collaboration with the Quality Director participates in strategic initiatives and corporate activities that impact FDA regulated materials
* Collaborate with corporate Quality team in meeting Quality objective
* 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 (e.g., Public Health)
* 10+ years of relevant cGMP and/or FDA experience in a manufacturing environment
* Good leadership and 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
* Solid knowledge of continuous improvement and Lean Six Sigma methodologies (DMAIC, DFSS, Lean).
* Extensive knowledge of Quality System and Product Regulatory requirements (ISO 9001:2015 / ISO 13485:2006 / cGMP / HACCP / etc.)

* Knowledge of EU, USP, ICH, FSMA & IPEC preferred
* Certified Black Belt#WRGrace

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

Tuition Reimbursement

Company Donation Match Program#WRGrace