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.

 

POSITION SUMMARY

 

The Manager, Manufacturing Assurance is 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.

 

ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.

• 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.
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA regulations.
• Adhere to departmental corporate safety policies.
• Work closely with Quality Assurance on the Quality Risk management Process in gathering, organizing and reporting of Risk associated with deviations, unusual events, or similar, as needed

 

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL 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 qualified individuals with disabilities to perform the essential functions.

 

• 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.

 

 

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 Manager, Manufacturing Assurance role based in California, is $124,790 to $145,000 per year. Additionally, the position is eligible to participate in up to 15% 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.

California Personnel Privacy Policy and Notice at Collection

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

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