CM Quality and Regulatory Affairs Site Leader
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Job Location:
Monthly Salary:
Posted on:
30 days ago
Vacancies:
1 Vacancy
Job Summary
Job Summary
The CM Quality and Regulatory Affairs Site Leader is responsible for overseeing and maintaining the sites Quality Assurance Quality Control and Regulatory Affairs functions for the Contract Manufacture Sites ensuring full compliance with applicable regulations including USDA-CVB FDA and other national or international authorities as required. This role encompasses strategic oversight of the Quality Management System (QMS) batch testing batch release regulatory submissions process validations calibration programs and internal audits. The position also manages quality systems and training programs to ensure operational readiness and regulatory alignment. The role requires close interaction with cross-functional teams regulatory bodies and external laboratories to support product lifecycle activities and maintain consistent compliance with Good Manufacturing Practices (GMP). The position is critical to ensuring the quality safety and regulatory integrity of all products manufactured and released by the Contract Manufacture sites.
The CM Quality and Regulatory Affairs Site Leader is responsible for overseeing and maintaining the sites Quality Assurance Quality Control and Regulatory Affairs functions for the Contract Manufacture Sites ensuring full compliance with applicable regulations including USDA-CVB FDA and other national or international authorities as required. This role encompasses strategic oversight of the Quality Management System (QMS) batch testing batch release regulatory submissions process validations calibration programs and internal audits. The position also manages quality systems and training programs to ensure operational readiness and regulatory alignment. The role requires close interaction with cross-functional teams regulatory bodies and external laboratories to support product lifecycle activities and maintain consistent compliance with Good Manufacturing Practices (GMP). The position is critical to ensuring the quality safety and regulatory integrity of all products manufactured and released by the Contract Manufacture sites.
Duties and responsibilities
and manage the Quality Management System (QMS):
Establish oversee and maintain quality systems and processes to ensure compliance with applicable regulatory standards and industry best practices while fostering a culture of continuous improvement and quality across the organization. Such as: Document Management System Risk Assessment Management System System of Complaints recall customer service and sales Change Control System and others.
for Quality Control management:
Supervise all the testing of finished products raw materials and intermediates ensuring compliance with specifications and regulatory requirements prior to distribution or use.
for Quality Assurance Release management:
Supervise and approve the release of finished products raw materials and intermediates ensuring compliance with specifications and regulatory requirements prior to distribution or use.
deviation non-conformance and CAPA processes:
Oversee investigations root cause analyses and the implementation and follow-up of corrective and preventive actions to ensure effective resolution and recurrence prevention.
and coordinate audits:
Define the internal audit schedule and manage regulatory and client audits ensuring preparation execution and closure of findings in alignment with compliance expectations.
training and qualification programs:
Administer quality and regulatory compliance training programs to ensure staff remain aligned with applicable standards and expectations.
supplier quality management:
Supervise the evaluation selection and ongoing monitoring of critical suppliers to ensure adherence to quality requirements.
and ensure adaptation to current regulations:
Stay informed on national and international regulatory changes and coordinate the implementation of necessary adjustments to internal systems and processes.
regulatory affairs activities:
Supervise the preparation submission and follow-up of regulatory documentation product registrations licenses and renewals with the appropriate authorities.
as regulatory authority liaison:
Act as the main point of contact during regulatory inspections and audits managing responses and corrective actions as needed to maintain compliance.
validation and calibration programs:
Oversee the planning execution and maintenance of process facility and equipment validations as well as the calibration of critical instruments and systems.
on-floor quality inspections:
Administer and coordinate routine inspections on the production floor to ensure adherence to GMP and quality standards facilitating identification of risks and implementation of corrective actions.
official sampling and submission process:
Ensure proper execution of official sampling activities and manage the documentation and shipment of samples to designated laboratories and to the Center for Veterinary Biologics (CVB) in full compliance with applicable requirements.
Oversee investigations root cause analyses and the implementation and follow-up of corrective and preventive actions to ensure effective resolution and recurrence prevention.
and coordinate audits:
Define the internal audit schedule and manage regulatory and client audits ensuring preparation execution and closure of findings in alignment with compliance expectations.
training and qualification programs:
Administer quality and regulatory compliance training programs to ensure staff remain aligned with applicable standards and expectations.
supplier quality management:
Supervise the evaluation selection and ongoing monitoring of critical suppliers to ensure adherence to quality requirements.
and ensure adaptation to current regulations:
Stay informed on national and international regulatory changes and coordinate the implementation of necessary adjustments to internal systems and processes.
regulatory affairs activities:
Supervise the preparation submission and follow-up of regulatory documentation product registrations licenses and renewals with the appropriate authorities.
as regulatory authority liaison:
Act as the main point of contact during regulatory inspections and audits managing responses and corrective actions as needed to maintain compliance.
validation and calibration programs:
Oversee the planning execution and maintenance of process facility and equipment validations as well as the calibration of critical instruments and systems.
on-floor quality inspections:
Administer and coordinate routine inspections on the production floor to ensure adherence to GMP and quality standards facilitating identification of risks and implementation of corrective actions.
official sampling and submission process:
Ensure proper execution of official sampling activities and manage the documentation and shipment of samples to designated laboratories and to the Center for Veterinary Biologics (CVB) in full compliance with applicable requirements.
Qualifications
Education: Bachelors degree in Life Sciences Pharmacy Biotechnology Chemistry or a related field is required. An advanced degree (e.g. MSc PhD MBA) is considered an asset.
Experience: Minimum of 57 years of progressive experience in Quality Assurance and Regulatory Affairs within the pharmaceutical biotechnology or biologics industry. Experience working under USDA Center for Veterinary Biologics (CVB) regulations is strongly preferred.
Additional experience with FDA EMA or other regulatory frameworks is highly desirable.
Technical Knowledge: Solid understanding of cGMP GLP and other applicable quality and regulatory standards. Familiarity with validation protocols calibration programs quality systems (QMS) deviation/CAPA processes and batch release. Experience managing regulatory submissions and interactions with authorities (e.g. CVB FDA).
Skills:
Strong analytical and problem-solving skills.
Excellent organizational and project management capabilities.
Proficient in quality systems software and document control platforms.
Clear professional verbal and written communication skills in English.
Ability to interpret and apply complex regulatory requirements to operational environments.
Demonstrated ability to manage teams and processes with accountability and independence.
Comfortable making compliance-driven decisions under time constraints.
High ethical standards attention to detail and commitment to continuous improvement.
Strong organizational planning and project management abilities.
Proficiency in data analysis KPI tracking and business reporting.
Effective problem-solving and decision-making under pressure.
Ability to lead cross-functional teams in a regulated environment.
Ability to develop and implement strategic and operational plans.
Capacity to manage multiple priorities and drive results under tight timelines.
Comfortable working in a hands-on dynamic and evolving operational setting.
Demonstrated leadership in managing cross-functional teams and multi-disciplinary operations.
Excellent communication strategic planning and problem-solving skills.
Fluent in operational excellence tools and quality systems (e.g. GMP SOPs audit readiness).
Hands-on leader with the ability to drive engagement and deliver results through others.
Certifications & Requirements
Valid drivers license with a clean driving record.
Ability to handle hazardous chemicals and manage safety protocols.
Working conditions
Location: This position is based on-site at Adel Iowa. Limited travel may be required for audits inspections training regulatory meetings or visits to contract manufacturing (CM) sites of VALO BioMedia and other external partners.
Environment: The role involves working in both office and regulated production or laboratory environments. Use of personal protective equipment (PPE) may be required when entering GMP-controlled or cleanroom areas.
Work Schedule: Full-time position (typically Monday to Friday). Flexibility may be required during audits regulatory inspections or urgent operational events.
Participation in emergency response including alarm call-outs may be expected on a rotational or as-needed basis.
Occasional travel may be required for training audits or corporate meetings
Exposures: Hazardous chemicals pesticides electrical systems flammable gases dirty environment
Devices: The position includes a company issued laptop and cell phone
Physical requirements
Ability to sit stand and work at a computer for extended periods of time in an office environment.
Ability to walk through manufacturing laboratory and warehouse areas including entering GMP-controlled environments and cleanrooms when required.
May be required to wear appropriate personal protective equipment (PPE) including gowns gloves masks and safety glasses depending on the work area.
Ability to perform visual inspections and review documentation in standard and controlled lighting conditions.
Occasionally required to lift carry or move materials and documents weighing up to 25 lbs.
Must be able to respond to on-site needs during audits inspections or quality-related investigations.
Integrity & Confidentiality
The Site Leader must uphold a high level of integrity and confidentiality. This role is expected to build a long-term relationship with the company demonstrating commitment and reliability.
Direct reports
The CM Quality and Regulatory Affairs Site Leader is responsible for overseeing all personnel and activities related to quality control quality assurance and regulatory affairs within the CM business of VALO BioMedia.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
