Share this Job

Global Compliance Manager

Date: Sep 27, 2022

Location: Columbia, MD, US, 21044

Company: W. R. Grace & Co.

Requisition ID: 20987 

Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company’s two industry-leading business segments—Catalysts Technologies and Materials Technologies—provide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 4,300 people in over 30 countries.

Job Description

Grace is seeking a Manager, Quality Compliance 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 Manager, Quality Compliance 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. 

Responsibilities

•    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. 

Required Qualifications

•    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).  Certified Black Belt preferred.
•    Extensive knowledge of Quality System and Product Regulatory requirements (ISO 9001:2015 / ISO 13485:2006 / cGMP / HACCP / etc.)

Preferred Qualifications

 

  • Knowledge of EU, USP, ICH, FSMA (preferred), IPEC (preferred)

#WRGRACE

Benefits

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

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.


Nearest Major Market: Baltimore