Manager, Document Control

Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Manager, Document Control to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics.

POSITION SUMMARY:

This role is responsible for leading the Document Control function and overseeing the management, implementation, validation, and maintenance of electronic Quality Management Systems (eQMS) and potentially interfacing Product Lifecycle Management (PLM), Manufacturing Execution System (MES), and Enterprise Resource Planning (ERP) systems. The Manager will ensure all aspects of document and record control comply with FDA regulations (including 21 CFR Part 11), ISO 13485, ISO 9001, and other relevant standards. This position requires hands-on experience in implementing SaaS-based quality systems and validating them according to regulatory requirements within the life-science industry.

ESSENTIAL FUNCTIONS:

The functions/responsibilities outlined in this Job Description have an impact to the company’s QMS and product quality. These may include, but are not limited to:

Document Control Leadership

• Manage the complete lifecycle of all controlled documents (SOPs, specifications, work instructions, forms, drawings, etc.) including creation, review, approval, distribution, revision control, archiving, and obsolescence.
• Lead, mentor, and develop the Document Control team/staff.
• Establish and maintain efficient document control processes and procedures.
• Manage the Engineering and Document Change Order (ECO / DCO) processes.
• Maintain the master document list and ensure timely updates.

eQMS & SaaS System Management

• Serve as the primary system administrator and subject matter expert (SME) for the company's eQMS platform and potentially related SaaS systems (PLM, MES, ERP interfaces impacting quality records).
• Manage system configuration, user roles, permissions, and workflows within the electronic systems.
• Lead or play a key role in the selection, implementation, data migration, and rollout of new or upgraded SaaS-based eQMS, MES, PLM, or relevant ERP modules.
• Develop and maintain system documentation, work instructions, and training materials for users.

Software Validation (21 CFR Part 11)

• Ensure that the eQMS and other relevant electronic record-keeping systems are implemented and maintained in compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures.
• Lead or significantly contribute to the validation of these systems, including developing Validation Plans (VP), User/Functional Requirement Specifications (URS/FRS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Oversee the execution of validation testing and ensure proper documentation of results.
• Manage the change control process for validated systems and conduct periodic reviews to ensure continued validated state.

Compliance & Audits

• Ensure all document control practices and electronic systems meet the requirements of FDA 21 CFR 820, ISO 13485, ISO 9001, 21 CFR Part 11, and other applicable regulations.
• Act as the primary SME for document control and electronic system validation during internal audits and external regulatory inspections (e.g., FDA, Notified Body).
• Oversee the management and archiving of quality records, both physical and electronic, ensuring their integrity and retrieval.

Training & Support

• Develop and deliver training to company personnel on document control procedures, GDP (Good Documentation Practices), and the use of the eQMS and related systems.
• Provide ongoing support to users of the document control and electronic quality systems.

EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED:

Education & Experience:

• Bachelor's degree ideally in a technical, scientific, IT, or business field. MS preferred.

• Minimum of 7-10 years of experience in Document Control within the life science industry.
• Minimum of 5 years of experience in management role overseeing document control staff or projects.
• Proven, hands-on experience leading in the implementation and administration of SaaS-based systems (specifically eQMS, experience with PLM or ERP is a strong plus) in a regulated GxP environment.
• Direct, demonstrable experience with computer system validation (CSV) activities compliant with FDA 21 CFR Part 11, including developing validation documentation (protocols, reports) and managing the validation lifecycle for electronic systems.
• Experience managing complex data migration projects during system implementation.
• Experience in developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for electronic systems.

Job Complexity:

Manages personnel and monitors operations of a unit or sub-unit. Works on issues of broad scope and complexity and uses judgement to analyze situations based on data and relevant facts. Requires full knowledge of own area of functional responsibility. Establishes policies and procedures with potential impact to other areas of the organization.

Supervision:

Provides direct supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. A portion of time is normally spent performing individual tasks related to the unit or sub-unit. Generally may supervise semi-skilled and skilled personnel.

Normally receives little instruction on day-to-day work; independently manages the coordination of activities of a section or department with responsibility for resources, methods, and results.

Responsible for a high level of internal and external partnerships and for interacting in a manner that reflects positively on the department and is consistent with the company’s policies and core values.

Knowledge, Skills & Abilities:

• Strong leadership and team management skills.
• Exceptional organizational skills and meticulous attention to detail.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Proficiency in project management, especially related to system implementations.
• Technical aptitude for system administration, configuration, and troubleshooting.
• Ability to train others effectively.

TECHNICAL KNOWLEDGE

• Expert knowledge of FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, ISO 9001 requirements related to document control and records management.
• Expert knowledge of FDA 21 CFR Part 11 regulations for electronic records and electronic signatures.
• Strong understanding of document lifecycle management, change control processes, and Good Documentation Practices (GDP).
• Familiarity with the architecture and functionality of common eQMS, PLM, and ERP systems.
• Experience with eQMS platforms (e.g., MasterControl, etq).
• Experience with PLM, MES, and ERP systems (e.g., IFS, ePDM, VisualFactory).
• Experience with Label Printing Software and Hardware (e.g., Bartender, Zebra).

EFFORT REQUIRED:

Physical Activities:

On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL:

This position may require limited travel.

This is an on-site position in San Diego with an annual salary range of $127,000 - $164, 000, based on experience and qualifications

Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.

Equal Opportunity Employer
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