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 for Quality Assurance Technical Manager role based in California, is$95,230.35 - $119,038.80 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and 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!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CALearn more about Grifols
