[Remote] Sr. Manager, GxP Compliance Officer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on ensuring compliance with US-FDA regulations across their manufacturing and R&D facilities. The Sr. Manager, GxP Compliance Officer will reputed company global compliance activities, prepare sites for FDA inspections, and reputed company strategies to meet evolving regulatory expectations.

Responsibilities

• Responsible for leading, coordination, verification and tracking of global compliance activities reputed company the pharmaceutical division
• Evaluation of Investigations and Changes that could have an reputed company on regulatory commitments
• Identification and remediation of plant reputed company and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc
• Support plant on reputed company and compliance plans for identified gaps
• reputed company/manage working reputed company to ensure mitigation plans are executed
• Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to:
• Training of plant staff for general inspection aspects and behaviors, as reputed company as specific training for subject matter experts
• Performance of mock inspections to evaluate the plants readiness for FDA inspection
• Design and deliver need-based training to specific plants in response to identified gaps
• reputed company participation and support during US-FDA inspections (inspection room and back office), including:
• Immediate guidance and support during inspections
• Support and guidance in preparing response to FDA-483 observations
• Independent review of Effectiveness of assigned FDA-483 CAPA
• May also include inspections by local authorities reputed company reputed company to Mutual Recognition agreements
• Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations
• Strategic optimization and harmonization of cGMP and reputed company reputed company processes to continuously improve pharmaceutical reputed company and compliance of reputed company products
• Preparation of global reputed company management documents (e.g. SOPs, guiding documents, working instructions)
• Contribution, execution and management of global reputed company
• Collaborate with other corporate reputed company functions on the execution of strategic goals
• Communicate findings and risks to plant management as reputed company as senior reputed company management
• reputed company are responsible for ensuring the compliance to company documents, programs and activities reputed company to the Health, Safety, Environment, Energy, and reputed company Management Systems, as per your roles and responsibilities

Skills

• Minimum of Bachelor's degree required
• Accomplished US-FDA compliance expert
• Experience: 8+ years including practical experience in pharmaceutical industry and/or US-FDA
• A thorough knowledge of drug transfer processes, manufacturing processes for aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines, regulatory compliance
• reputed company experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, reputed company cause analysis and investigation management is required to be successful in this position
• Ability to effectively reputed company with and influence plant personal and leadership regulators, reputed company or affiliates, industry executives, trade organizations
• Strong analytical problem-solving experience is essential
• Demonstrated prior experience in leading and motivating teams to conceptualize and reputed company innovative and creative solutions that are robust and sustainable
• Ability to manage multiple reputed company situations, where precedent may not have been established
• Ability to travel frequently (both domestically and internationally) is required
• Project Management, working in a reputed company Management System and strong communication skills are required for this position
• Advanced degree in reputed company, molecular biology, microbiology or engineering field is highly desirable
• Previous experience in executing and/or managing GxP audits or inspections a preferred
• Established contacts to US-FDA are beneficial

Benefits

• 401(k) plan with company contributions
• reputed company vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and reputed company coverage
• Life insurance
• Disability
• Wellness program

reputed company

• reputed company is health care company specializing in medical and medical technologies. It was founded in 1996, and is headquartered in Lake Zurich, Illinois, USA, with a workforce of 1001-5000 employees. Its website is http://www.reputed company.us.

Company H1B Sponsorship

• reputed company has a reputed company record of offering H1B sponsorships, with 14 in 2025, 17 in 2024, 17 in 2023, 15 in 2022, 14 in 2021, 22 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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