Project Manager, Manufacturing Assurance

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.

Summary:                                                                        

Key individuals lead cross functional teams through investigations of high visibility, high risk manufacturing deviations, environmental monitoring excursions, and calibration investigations.  Drives departmental projects to completion through providing leadership and cross functional management to all personnel and functions involved. Provides management of projects to meet appointed timelines and achievement of required completion dates.                                                        

Primary responsibilities for role:                                                                       

• Lead cross functional teams (Quality Assurance, Manufacturing, Maintenance, Quality Control, Quality Operations, Stability, etc), through the investigation process for high visibility, high risk deviations.                 
• Responsible for identification and resolution of roadblocks and streamlining, where possible, for investigation closures and project milestones/ timeline          
• Drive departmental projects to completion through providing leadership and management to all personnel and functions involved.                                                       
• Responsible for monitoring and updating project status and communicating this information to management.
• Assume the decision-making responsibility for day-to-day operations, in the absence of the Department Manager, considering staff input and collaborating with other GB functions.                                                                 
• Work closely with the Manufacturing and Quality Assurance departments to ensure prompt closure of deviation reports.
• Perform thorough investigations, identify root causes, and determine corrective actions.                                     
• Identify areas where deviation/corrective maintenance reoccurrence could be avoided.
• Review manufacturing, facilities, environmental monitoring documentation and other documentation, as required, to generate an investigation report. 
• Document completed investigations by generating formal written reports that summarize findings and corrective actions to be implemented.                              
• Maintain current knowledge of regulatory and industry standards.                      
• Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.                         
• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.                                   
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA regulations.                    
• Perform Facility and Utility area inspections and report any findings with potential impact to department and area manager
• Perform Facility and Utility area inspections and report any findings with potential impact to department and area mana
• Assist in CAPA generation, execution, implementation, DCM Submission, Plant Change control or similar               

Job Requirements:

• Bachelor of Science degree in Engineering, Biology, Chemistry, Biochemistry or closely related scientific / technical discipline or equivalent work experience
• Minimum of 5 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required.  Knowledge of conducting or assisting with Manufacturing deviation investigations required. Experience in leading cross functional teams to drive results and experience with project management is preferred.
• Requires an in depth understanding of pharmaceutical manufacturing 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, validation, and/or aseptic processing is preferred.  Experience in conducting investigations is required. 
• Must have strong technical writing skills. 
• 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 interpersonal skills with the ability to interact with personnel at all levels in a team environment. 
• Excellent verbal and written communication skills in the English language.  Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Resolve potential conflicts of interest to reach a positive outcome for all departments involved.
• Adhere to departmental corporate safety policies. 
• Trains entry level personnel. 
• Performs more complex and advanced job tasks.
• Assist management in coordinating and scheduling the department's day to day operations. 
• Serves in a leadership role in the absence of direct supervision. 
• Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.

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. 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 complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

The estimated pay scale for Project Manager, Manufacturing Assurane role based in California, is $80,000 -$100,000 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.

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.

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

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