Quality Assurance Technical Manager

Socket.dev; Los Angeles (CA); On-site; USD 95,000 - 119,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO

401(k) match

Tuition reimbursement

Paid holidays

Job summary

Grifols in California seeks a Quality Assurance Technical Manager to lead regulatory submissions to the FDA and other agencies, coordinating technical documentation to meet timelines.

You will review validation protocols and CAPAs, provide technical guidance, and interact with auditors to ensure compliance in a global healthcare setting.

Qualifications

• Bachelor’s degree in the sciences or related field.
• Minimum 5 years’ experience in Quality Assurance, Regulatory Affairs, Compliance, Quality Engineering or Quality Control in pharma/biotech with cGMP/GLP emphasis.
• Comprehensive knowledge of cGMP, FDA, EU and other regulatory requirements, and industry guidelines.
• Strong writing, organizational and communication skills; able to work independently.

Responsibilities

• Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation.
• Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols and reports.
• Perform compliance reviews of Validation CAPAs and ensure complete and accurate information.
• Interface with cross-functional groups to ensure accuracy of regulatory submissions and information requests.
• Participate in regulatory inspections/audits and provide written responses as needed.
• Maintain knowledge of FDA, EU and other regulatory standards; release approved regulatory changes in SAP.

Skills

Regulatory affairs

cGMP/GLP

Technical writing

Regulatory submissions

Audits

Education

Bachelor’s degree in the sciences or related field

Tools

SAP

MS Office

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Job Summary:

Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet submission timelines. Review and approve Validation and Research & Development documents. Perform compliance reviews of Validation CAPAs for confirmation that all action items were satisfactorily addressed and verify the completeness and accuracy of information.

Essential Job Duties:

• Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation required to meet submission timelines.
• Review and approve validation IQ, OQ, PQ, CQ, FEQ, AMF and PV protocols and reports.
• Perform compliance reviews of Validation CAPAs for confirmation that all action items were satisfactorily addressed and verify the completeness and accuracy of information.
• Interface with various groups to ensure that content in complex technical submissions and information requests to the FDA and other regulatory agencies is accurate and complete.
• Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.
• Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards.
• Release approved regulatory changes in SAP for implementation in manufacturing
• Review and approve R&D stability and characterization protocols and final reports.
• Provide scientific and/ or technical advice regarding projects and validations as needed.
• Author and/or edit Standard Operating Procedures (SOPs), License Specifications (LSs), regulatory submissions and other documents.

Job Requirements:

• Bachelor’s degree in the sciences or related field.
• Minimum 5 years’ experience in Quality Assurance, Regulatory Affairs, Compliance, Quality Engineering or Quality Control, in the pharmaceutical or biotech industry, with a strong emphasis on cGMP and GLP concepts.
• Comprehensive knowledge and understanding of cGMPSs, FDA, EU and other regulatory agency requirements, and industry guidelines.
• Ability to work independently with minimum supervision.
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong technical writing and interpersonal skills with the ability to interact with personnel at all levels. Excellent verbal and written communication skills.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Provide regular status updates to senior management.
• Maintain a quality presence to ensure compliance with all regulatory requirements.

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

*This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.

The estimated pay scale forQuality Assurance Technical Manager role based inCalifornia, is$95,230.35 - $119,038.80 per year. Additionally, the position is eligible to participate in up to 8%of thecompanybonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision,life insurance,PTO,paid holidays andup to 5% 401(K) match and tuition reimbursement. Final compensation packages willultimately dependon education, experience, skillset, knowledge, where the role is performed, internalequityand market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Location:NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA