Global Compliance Manager

Baltimore, MD | Fully Remote

Posted: 01/17/2023 Industry: Environmental, Health & Safety Job Number: 2.23CM Pay Rate: 120,000 - 145,000 Experience:

Job Description

Global Compliance Manager

Global private organization is looking for a Compliance Manager with strong FDA compliance expertise to oversee compliance for their continued growth in the life sciences arena.

The Global Compliance Manager, MT is responsible for promoting and supporting a culture of quality, compliance, and safety for the Food and Pharmaceutical segments with company’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

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at cmeeks@cps4jobs.com.

JO:  2.23CM
#LI-CM1

Job Requirements

Technical Qualifications:

  • 4-year BS 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.)

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at cmeeks@cps4jobs.com.

JO:  2.23CM
#LI-CM1

Meet Your Recruiter

Crystal Meeks
Sr. Technical Recruiter Environmental Health and Safety

My team recruits for all levels of EHS/Regulatory roles from specialists/engineers to directors/vice presidents. We place EHS professionals in single site, regional, and corporate positions. Examples of the specialty roles we recruit for include, but are not limited to:

• Environmental
• Environmental, Health, and Safety
• Industrial Hygiene
• Management of Change
• Occupational Nurse
• Process Safety Management
• Product Stewardship
• Regulatory
• Risk Management
• Safety
• Security

Industries we serve include, but are not limited to:

• Chemicals
• Construction
• Consumer Products
• Food & Beverage
• General Manufacturing
• Inks and Adhesives
• Medical Devices
• Packaging
• Paints & Coatings
• Petrochemical
• Pharmaceutical
• Plastics
• Polymers
• Refining


If you have interest in finding an opportunity that aligns with your career goals, or if you are a hiring manager looking for talent that can add value to your organization, I would love to hear from you! CMeeks@cps4jobs.com    312.668.8985

My recruitment philosophy encompasses the belief that people are the greatest asset in an organization.  Finding the right fit is not only about the technical capabilities.  It is about how an employee fits within an organization's culture and ensuring that both parties can add value immediately and in the future.   

 

 

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