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Manager, Manufacturing Assurance
GrifolsManager of Manufacturing Assurance responsible for reviewing manufacturing investigations at Grifols. Ensuring compliance and leading a team in a pharmaceutical environment.
Posted 5/19/2026full-timeLos Angeles • California • 🇺🇸 United StatesMid-LevelSenior💰 $124,790 - $145,000 per yearWebsite
About the role
Key responsibilities & impact- Responsible for the review of all investigations for deviations, environmental monitoring excursions and calibration investigations related to Manufacturing, Maintenance and Packaging and assessing the impact on product and/ or production.
- Oversees the completion of investigation reports, including identification of product impact root causes and determination of corrective actions.
- Work closely with the Manufacturing, Quality Assurance, Maintenance/ Facilities, and other departments to ensure prompt closure of deviation reports.
- Identify areas where deviation/corrective maintenance reoccurrence could be avoided.
- Review manufacturing, facilities, environmental monitoring documentation and other documentation, as required, to ensure it supports the investigation reports generated by the team.
- Manage and monitor department's operating budget.
- Assume the decision-making responsibility for day-to-day operations considering staff input and collaborating with other GBI functions.
- Provide scientific and/or technical advice and counsel regarding projects as needed.
- Communicates company and departmental goals to the department's exempt and non-exempt employees.
- Communicates with cross functional departments and support groups to improve departmental performance and efficiency.
- Maintain current knowledge of regulatory and industry standards.
- Review investigations, reports generated for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses for area of responsibility, if necessary.
- Provide guidance and hands-on training to direct reports.
- Appraise and monitor performance of department personnel.
- Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources, as necessary.
- Provide a leadership role ensuring employee health and safety.
- Involved in interviewing/selection process of hiring or promoting department personnel.
Requirements
What you’ll need- Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific/technical discipline is required.
- Minimum of 5 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.
- Minimum of 3 years of managerial, supervisory, or leadership experience in a related industry is required.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Requires an in depth understanding of pharmaceutical manufacturing/ packaging and laboratory processes/ equipment (ultrafiltration, CIP, chromatography, reactor tanks, centrifuges, filter presses, etc.).
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
- Direct hands on experience in manufacturing, packaging, validation, and/or aseptic processing is preferred.
- Experience in conducting / reviewing/ overseeing investigations is required.
- Must have strong technical writing skills.
- Demonstrated ability to inspire high performance in others and align team members around shared goals.
- Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
- Demonstrated project management skills.
- 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.
- Excellent verbal and written communication skills in the English language.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Demonstrated knowledge of SAP, DCM and similar.
- Must be flexible with working hours/ shifts in order to accommodate the 24 hour, 7 day plant operation.
Benefits
Comp & perks- Medical
- Dental
- Vision
- life insurance
- PTO
- paid holidays
- up to 5% 401(K) match
- tuition reimbursement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical manufacturingpackaging processeslaboratory processesultrafiltrationCIPchromatographyreactor tankscentrifugesfilter pressestechnical writing
Soft Skills
interpersonal skillsleadership skillsorganizational skillsanalytical skillsproblem-solving skillsproject management skillscommunication skillscoachingtrainingdecision-making