Job Description

Job Description

Job Description

At BioSpectra we pride ourselves on how we efficiently support the top 25 pharmaceutical companies in the world, and we’re proud to set the standard for success in our industry. To help us continue growing, we’re seeking an experienced Regulatory Compliance Manager to join a highly skilled team.

The ideal candidate will ensure that all BioSpectra sites are always audit-ready through the performance of Compliance Inspections and Internal Audits. Additionally, they will ensure Customer Audits are executed in accordance with BioSpectra and Industry expectations. Moreover, attention to detail, problem-solving skills, and ethical awareness are crucial in maintaining accuracy, compliance, and integrity to BioSpectra’s rigorous quality standards through timely and compliant dossiers for submission to regulatory agencies.

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API’s, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada.

Why should you join BioSpectra, Inc.?

• Support our current customers who are the top 25 pharmaceutical companies in the world
• Develop your career with a growing organization with ample opportunities for professional and personal development
• Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement)
• 401K Retirement Savings Plan – Company matches $2 per $1 of employee contribution on the first 4%
• Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays

Job Summary:

The Regulatory Compliance Manager will be responsible for the management and execution of the Compliance inspection Program, Internal Audit Program, Customer Audit Program, and Regulatory Affairs Program.

Essential Duties and Responsibilities:

• Ensures BioSpectra's Quality and Regulatory Programs and Systems are compliant with applicable regulatory standards, BioSpectra Policies and Customer Expectations.
• Prepares, compiles and maintains Regulatory dossiers including Drug Master Files, Veterinary Master Files, and Active Substance Master Files
• Authors, reviews and approves regulatory packets, quality policies and procedures
• Prepares and if required hosts customer and regulatory agency paper-based, virtual, and on-site audits and post audit activities and reports the events of the audit to key personnel.
• Executes the Customer Audit Program to ensure audits and follow up activities are compliant to internal, customer, and regulatory standards.
• Manages and executes the Compliance Inspection Program to ensure all sites are always audit ready
• Manages and executes BioSpectra's internal audit program and ensures compliance with current to regulatory standards and guidelines
• Lead Auditor for Internal Audits for the following systems Facilities and Equipment, Materials, Quality, Laboratory Controls, Production, and Packaging and Labeling operations or other records and data to determine the efficiency and effectiveness of systems.
• Completes Internal Audit Effectiveness Assessments to determine if an internal audit closure has been completed successfully or requires additional root cause analysis and CAPA.
• Coordinates with BioSpectra Departments for any Compliance Program related Corrective and Preventative Actions including assessment for Compliance to BioSpectra's Quality Agreements with Customers.
• Completes required regulatory and compliance documentation requests to support product commercialization.
• Reviews current and new Guidance Documents and implements an action plan for BioSpectra to incorporate any changes to the current Quality management System.
• Other duties may be assigned as deemed appropriate by the Director of Compliance

Qualifications:

• Four-year degree in Science or related field
• 5 years minimum experience working in a cGMP environment ideally Active Pharmaceutical Ingredient related
• Has a working knowledge and understanding of ICH Q7, 21 CFR 210 and 211, Part 11 and Annex 11
• Knowledge of Global Regulatory Affairs including but not limited to United States, European, Canada, and Asia
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Experience with relevant software applications including MS Office, Excel, Minitab and Adobe
• Ability to communicate effectively with staff, management, customers and/or regulatory agencies
• Ability to handle sensitive information in a confidential manner
• Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.

Work Hours:

• Exempt Position; Shift Hours: 8am to 5pm
• Minimum of 45-50 Hours Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities

Ready to make a difference in the biopharma industry? Apply now and be part of a talented team driving excellence at BioSpectra!

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Job Tags

Holiday work, Remote job, Shift work,

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