Senior Manager, Quality Systems

Job Description

POSITION SUMMARY:

We are seeking an experienced QMS Senior Manager to lead our quality management system initiatives and ensure the highest standards of product quality and regulatory compliance. The successful candidate will be responsible for overseeing and managing a wide range of quality processes related to quality systems audits, harmonization of quality system processes, finished product release, and equipment administration, in accordance with regulatory standards such as 21 CFR Parts 210, 211, 820, and 11, ISO 13485, and ICH Guidelines. Additionally, the individual shall employ independently selected methods / techniques and execute in-depth evaluations to address and resolve complex objectives and problems, including interface with internal and external resources when judged to be necessary.

Essential Functions And Responsibilities

These may include but are not limited to:

• Administer and monitor quality processes, ensuring conformance to regulatory standards, and track operational performance to identify improvement opportunities.
• Conduct data collection and analysis to support investigations and corrective actions,
• Manage the issuance of batch records for GMP production. Prepare and review lot number and expiration date calculations and ensure compliance of batch records with GXP requirements.
• Compile product release records into the eQMS system, issue product shipment authorizations.
• Assist in the maintenance and issuance of logbooks.
• Schedule calibration activities, support equipment qualification processes, and interface with cross-functional teams to ensure compliance to equipment administration program.
• Collaborate with other departments to maintain compliance and ensure product quality and patient safety.
• Facilitate the gathering of data for performance metrics, conduct training, and support audits and inspections by health authorities and third parties.
• Lead and manage aspects of quality systems, including CAPA, Management Review, Deviation Management, and Supplier Quality, while evaluating performance and compliance of quality system documentation.
• Drive continuous improvement efforts through the development and implementation of systems and resources, and lead the effort in screening document changes.
• Lead preventative action activities to support implementation of changes to 21 CFR Part 820 utilizing ISO13485 as its foundation.
• Lead and support internal and external audits, participate in supplier audits, and manage the field action process to ensure timely compliance.
• Support the complaint team in the review and investigation of customer complaints, including assessment of complaint outcomes for Medical Device Reports (MDR).
• Participate in Quality System harmonization activities across all Halozyme sites.
• Support Software Quality Assurance team in the utilization of eQMS software for manufacturing and quality event activities.
• Communicate effectively with all groups and lead/manage the quality system team, providing mentorship to team members
• Other duties as assigned
  
  

Education, Experience, Knowledge, Skills And Abilities

• Minimum BS/BA degree in a scientific or technology field, such as Engineering.
• Minimum 8 years of experience the life science industry.
• Minimum 5 years of experience in supervising a diverse group of employees.
• An equivalent combination of experience and education may be considered
• The candidate will possess broad experience within the Quality function combining excellent technical expertise and strong cross-functional communications skills.
• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
• In-depth knowledge of GXP, 21CFR, EU GMP, ICH, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance with hands-on experience in their interpretation and application to ensure compliance through practical and progressive approaches is achieved and maintained.
• Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
• Strong background in a manufacturing and operations environment preferably supporting drug-device combination products, medical devices, and/or aseptically-produced pharmaceutical products.
• Experience working within vertically integrated and virtually-structured settings for small- to mid-sized organizations is preferred.
• Strong background in administering and optimizing quality systems.
• Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.
• Ability to interface with internal customers at all levels and 3rd-party partners.
• Technical, equipment, software knowledge necessary
  
  

Environmental Conditions

Physical Activities: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

Travel

Travel may be required up to 5% of your time.

Pay Rate Range: $60-78/hr depending on experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.