Senior Manager, Quality

We are looking for a Sr. Quality Manager who will be responsible for leading and managing the development, implementation and continual improvement of Quality Assurance and Quality Control functions for our Manufacturing site. This position will ensure that Hyland’s products conform to company standards, GMP and regulatory requirements. This position will provide support, direction and coaching across the organization in collaboration with internal teams.

Essential Duties and Responsibilities include the following :

• Manages Quality functions (such as quality technicians, quality inspectors, product release, quality control, document control, and training) to provide needed support for manufacturing operations to ensure GMP compliance.
• The position has the GMP decision making authority over manufacturing processes, review and approval documents throughout the manufacturing processes, and Quality System documentation (deviations, investigations, change controls, etc.).
• Manages incoming inspection of components and testing of raw materials as well as release in accordance with established requirements.
• Ensures appropriate review and approval of Master Batch records, change control documentations, packaging and labeling documents, audit observations, product specifications, and analytical methods.
• Provides guidance to navigate rejected materials and appropriate investigations.
• Manages batch record issuance, batch record review, and product release processes at Hyland’s facility.
• Ensures that all deviations, including laboratory out-of-specification results occurring during manufacturing are investigated appropriately to ensure that necessary Corrective and Preventive actions are implemented.
• Reviews Change Controls to ensure proposed changes are justified, evaluated, and implemented to meet GMP requirements.
• Oversees Document Control function and SOP lifecycle management.
• Oversees Training Program to ensure all GMP employees have training plans based on job function which includes annual GMP training.
• Leads QC lab in compliance with regulatory requirements (GLP, USP, data integrity, etc.). Responsible for accuracy integrity of laboratory data.
• Overseas Deviation / CAPA program to ensure thorough investigations, product impact assessment, identification of the root cause and implementation of corrective action to mitigate recurrence.
• Support plant validation and qualification projects.
• Review internal quality KPIs and identify opportunities for improvements. Support compilation of bi-annual QMR data.
• Lead and participate in process improvement initiatives.
• Sustain Facility Walkthrough Program and oversee completion of resolutions to maintain plant inspection readiness.
• Work independently and ensure that documents tied to product release are prioritized.
• Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations.
• Responsible for ensuring adequate resources / staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to procedures.
• Responsible for communicating and / or facilitating personnel actions; including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, overtime, etc.
• May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities : This position will have responsibility of managing a select number of direct reports.

Qualifications : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and / or Experience

Knowledge, Skills, and Abilities

Physical Demands : The physical demands described here 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.

While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk and hear. The employee is occasionally required to stand, walk; use hands to finger, handle, or feel and reach with hands and arms. The employee may occasionally lift / move up to 10 pounds.

Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

This job description is subject to change at any time.

We are committed to a safe and nurturing workplace that honors the work of each of our associates and appreciates that each member of our team offers a unique contribution to our collective success.

If you enjoy working in this type of environment and want a challenging and exciting position, this may be the opportunity for you. We offer a comprehensive benefits package including Medical, Dental, 401K, PTO, and holiday pay.

For more product and company information, please visit

EQUAL OPPORTUNITY EMPLOYER

Notice to Job Applicants :

In accordance with California law, the expected salary range for this position is between $120,000 and $150,000 / year. The actual compensation will be determined based on experience, skills, and other factors as permitted by law.

Salary : $120,000 - $150,000