Associate Director, Validation

Grifols; Los Angeles (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) match

Paid time off

Tuition reimbursement

Job summary

Grifols is seeking an Associate Director of Validation in California to lead the GBIs Validation program, ensuring equipment, utilities, processes, facilities, and manufacturing systems meet cGMP and quality standards.

The role directs validation strategy, reviews protocols, manages priorities, collaborates with R&D, QC, Eng and Manufacturing, and supervises validation staff, while supporting a 24/7 plant operation in the Los Angeles area.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related discipline; Master’s/PhD preferred.
• 6 years of Validation experience in pharmaceutical GMP/FDA environment; 4+ years in management.
• Deep understanding of validation principles and qualification requirements for sterilization and aseptic processing.
• Solid knowledge of cGMPs and FDA regulations; leadership experience is preferred.
• Proven ability to inspire performance and manage projects in a team setting.

Responsibilities

• Direct GBIs Validation program in line with GMP and quality standards.
• Develop validation strategy and policy to streamline validation.
• Review and approve validation protocols and reports to meet regulatory requirements.
• Prioritize validation projects with emphasis on critical ones.
• Coordinate validation documentation for regulatory submissions.
• Lead and develop Validation personnel and manage staffing needs.
• Oversee Validation Master Plans/Schedules and respond to audits.
• Collaborate with R&D, Quality Control, Engineering, and Manufacturing.

Skills

Validation experience

Leadership

Project management

Analytical skills

Communication skills

MS Office

Education

Bachelor's degree in related field

Master's degree preferred

Tools

GxP systems

Job description

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.

Job Summary

The Associate Director of Validation supports the GBIs Validation program in accordance with current GMP and quality standards to ensure qualification of equipment, utilities, processes, facilities and supporting manufacturing systems.

Essential Job Duties

• Direct Grifols Biologicals LLC (GB) Validation program in accordance with current GMP and quality standards to ensure qualification of equipment, utilities, processes, facilities and supporting manufacturing systems.
• Essential Job Duties:
• Develops validation strategy and policy to streamline and simplify validation approach.
• Reviews and approves validation protocols and reports to ensure all regulatory and quality requirements are met and maintained.
• Generates and enforces priorities of validation projects, with maximum emphasis on the most critical projects.
• Coordinates validation documentation and justification for submissions required by regulatory agencies.
• Develops and implements methods, such as employee training, to increase validation knowledge and facilitate the adherence to GB’s validation policies.
• Responsible for maintenance of Validation Master Plans / Schedules for each area of manufacturing and packaging.
• Develops and implements responses to audit observations for validation concerns.
• Collaborates with Research and Development, Quality Control, Engineering and Manufacturing departments for validation planning: communicates validation standards and requirements.
• Directly supervises Validation personnel, including hiring, developing, motivating, and directing work in a manner that promotes the achievement of Validation business goals and objectives.
• Determines validation requirements for equipment, facilities, utilities, commodities and processes under Change Control and/or new projects; directs the completion of validation documentation before changes planned for the manufacturing plant are implemented.
• Oversees the work of the Filtered Air System's (FAS) department, including reviewing and approving FAS procedures, ensuring filter maintenance is performed as scheduled, and directing work in a manner that promotes the achievement of business goals and objectives.

Requirements

• Bachelor's degree in Computer Science, Engineering, Biology, Chemistry, Biochemistry, Physical Science, or related scientific/technical discipline required. An equivalent combination of education and experience may be taken into consideration. Master's degree and/ or Ph.D. is highly preferred.
• 6years of Validation experience in a pharmaceudical, GMP, or FDA reg enviroment. al device industry. Minimum of 4 years of managerial, supervisory, or leadership experience is required.
• Requires an in depth understanding of validation principles and qualification requirements for a range of systems, particularly sterilization systems and aseptic processing.
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Leadership experience in a related industry is preferred.
• 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.
• 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).
• 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. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels 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. 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

The estimated pay scale for Associate Director, Validation role based in California, is $160,000 - $190,000 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 in its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

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.

Location

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