Director/Senior Director – Quality Engineering And Regulatory

Company:

PBS Biotech, Inc

Department:

Quality

Position/Title:

Director/Senior Director – Quality Engineering and Regulatory

Location:

Camarillo, CA

Reporting To:

Exec. Director Quality

FLSA Status:

Exempt

Pay Range:

173k- 210k – 230k

GENERAL PURPOSE

This position is responsible for leadership and management of the Quality Engineering team and for establishing the regulatory role and associated responsibilities at PBS. Partnering with colleagues in Engineering, Manufacturing, Supply Chain, and Quality, this role supports product development, product transfer, validation, manufacturing, and commercialization of bioreactor products and processes. The Quality Engineering team provides product quality assessments, change impact assessments, and technical assessments supporting validations, qualifications, and certifications. Additionally, this position is responsible for developing, establishing, and maintaining relevant quality systems in support of product development and qualification.

Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Primary Responsibilities

• This role is considered a QA function and may provide QA approvals where assigned.
• Accountable for establishing and maintaining a system for definition and maintenance of regulatory requirements associated with PBS products (material assessments, product qualification reports, extractables, electrical safety certifications, etc.).
• Quality contact and approver for documents supporting product development, testing, verification, validation, and transfer of PBS products including bioreactor control units (electromechanical), single-use bioreactor vessels, and controller software.
• Accountable for establishing and maintaining finished goods shelf-life program.
• External regulatory/compliance liaison with PBS customers. Draft regulatory assessments associated with PBS products.
• Performs complex technical analysis and written assessments for product quality and compliance impact to validation due to changes or nonconformances.
• Serve as regulatory subject matter expert during customer regulatory/compliance audits.
• Mentor staff both within and outside of the Quality Engineering group.
• Accountable for management and maintenance of program for sterilization qualification, shipping/transport studies, packaging, and shelf life.
• Establish and formalize Regulatory role within the Quality Department at PBS
• Accountable for maturation of existing quality systems for risk management and validation.
• Partner with Engineering to further refine baseline requirements for product development and qualification, equipment verification/validation, material specifications, and design transfer. Develop templates for standard work.
• Accountable for maintenance of product quality master plan and site/facility validation master plan.
• Serve as a subject matter expert for internal and external audits by both Customers and Regulatory Agencies.

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

Knowledge/ Experience

• 5-10 years’ experience working in a quality system that requires a high degree of quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS9100), and/or ISO 9001.
• 4+ years in a validation or related role
• 5+ years in a technical or engineering role e.g. research, process development/engineering, manufacturing sciences, technical services, or analytical labs
• 10-12 years’ experience in a Quality role for medical products in a regulated environment (e.g. medical device, single-use medical and/or biopharma products, or similar field).
• Knowledge of lean, six sigma (e.g. DMAIC, DIDOV, etc.) and/or quality engineering (quality management system, product design and control, and continuous improvement, etc.) approaches and methodologies.

Skills/ Abilities Pertinent To This Position

• Risk management techniques related to ICH Q9, ISO 14971, or similar standards, including designing and applying FMEA, risk priority assignment, to product or process
• Ability to author technical assessments for regulatory purposes related to Pharma/Biotech (FDA CFR 210/211, ISO 13485/FDA CFR 820, EMA/EU Pharma, USP, AS 9100, or other federally regulated industry
• Statistical analysis, statistical process control, statistical sampling/acceptance methods, design of experiments, and related techniques
• Excellent technical writing and excellent verbal communication skills
• Program-level experience with validation or equivalent verification/validation, or qualification
• Experience leading and mentoring staff and colleagues
• Able to perform analysis to support material selection and qualification of pharmaceutical-grade materials

PHYSICAL DEMANDS

• In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
• This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment. May occasionally be required to perform some tasks in the following environments: Clean room; near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant; Personal protective equipment (vision and hearing) used in plant.
• Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing equipment. May occasionally required to lift various weights up to 25lbs (equivalent to 1 box of documents) as needed to meet job requirements.
• WORK ENVIRONMENT
• In general, the following physical demands 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 allow differently-abled individuals to perform the essential functions of the job.

NXTThing RPO is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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