Director, IGIV Production

Job Summary: 

Responsible for direct leadership over Bulk IGIV manufacturing operations, ensuring production goals are achieved through current Good Manufacturing Processes. Creates and/or maintains an overall strategy plan for their area of responsibility and ensure alignment with overall business goals.

Essential Job Duties:

• Oversees the 24/7 day-to-day operations of the Bulk IGIV manufacturing group, evaluating performance towards the achievement of production goals while maintaining regulatory compliance and minimizing errors.


• Assumes the decision-making responsibility for day-to-day operations considering staff input and collaborating closely with other functions (i.e. Quality, Maintenance, Validation, Engineering, etc).


• Directly supervises IGIV manufacturing managers and supervisors, including hiring, developing, and motivating in a manner that promotes the achievement of IGIV manufacturing’s business goals and objectives.                                           


• Manage and monitor IGIV Manufacturing operating budget.                                                                


• Meets all production and release requirements, maximizing yields and efficiency and reducing quality issues.                 


• Partner with the Quality and Manufactruing Asurance groups to review deviation investigation reports for accuracyand identify root cause/ corrective actions for IGIV Purification related incidents.                                                                          


• Build organizational competency and succession plans.                                                                      


• Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsible


• Provide scientific and/or technical advice and counsel regarding projects as needed                                                                         


• Develops and challenges managers and supervisors to find ways to improve manufacturing efficiency and reduce costs while maintaining product quality and compliance.


• Maintains clear communication with the VP of Manufacturing regarding goals, projects, planning, and overall performance of the bulk manufacturing group.


• Actively develops the capabilities of the staff, while creating an environment where employees want to work—one that supports engagement, job satisfaction, professional growth, and a culture of trust, respect, and accountability.


• Improves product quality and maintains compliance with respective federal and international regulations for cGMP's, governmental compliance and corporate standards.


• Assures a high level of safety awareness, compliance and performance by providing training and leadership in the prevention of accidents by assuming a proactive approach to safety and injury prevention.


• Partner with the Quality group to approve or reject all revisions and changes to IGIV Purification processes, procedures, specifications as well as Validation protocols and reports that will allow or disallow the use of facilities, equipment , materials or processes.                                                                                                 

Requirements:

• Master’s degree or Ph.D. in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related scientific/technical discipline..


• Minimum 10 years of operations experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, or medical device industry.  Minimum 5 years of managerial experience in an FDA regulated environment.


• Strong knowledge of cGMPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.


• Project management experience. 


• Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates. 


• Excellent verbal and written communication.  Must be able to read, write, and speak English. 


• Must have strong technical writing skills. 


• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. 


• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. 


• Strong organizational, analytical and problem-solving skills. 


• Ability to analyze details and perform structured decision-making on a daily basis.

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, frequently travels within the United States, occasional international travel.  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. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

*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 X role based in California, is $X-$X per year | per hour. Additionally, the position is eligible to participate in up to X% 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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