Job Overwiew:

Responsible for managing all aspects (i.e. quality systems, documentation, laboratory operations, compliance, training, staffing and budgetary needs, etc.) of a Quality Operations (QO) business unit within QO Supply Chain, Product Quality Management, or Compliance, Audits, and Systems.

Essential Job Duties:

• Manages all aspects of a Quality Operations business unit (quality systems, documentation, laboratory operations, overall compliance, oversee department budget, employee relations, etc.).
• Follows cGMP and department safety practices.
• Provides guidance as well as consult with manufacturing and internal regulatory departments on GXP matters.
• Uses expertise and sound judgment to make independent decisions within defined areas of responsibility.
• Plans and analyze work flow, delegate and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget.
• Participates in regulatory and internal inspections/ audits including providing written responses as applicable for area of responsibility.
• Practices high level of facilitations skills to reach consensus and works toward solutions.
• May review and revise Standard Operating Procedures and generate reports
• May investigate and initiate corrective action places for quality related issues
• Provides effective leadership to employees in Quality operations.
• Demonstrates high levels of value and integrity.
• Excellent communication skills (written and verbal) and extensive working knowledge of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

Job Requirements:

• Bachelor’s degree in life science or closely related field is required. Certification to a quality professional organization, e.g. ASQ CQA is highly preferred.
• 8 years of extensive quality assurance/quality compliance experience working in a domestic and global manufacturing matrixed environment within a pharmaceutical, medical device, GMP or FDA regulated industry.
• Must be able to demonstrate a deep knowledge of pharmaceutical, biotech, or medical device Quality Assurance/Quality Systems and theory.
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, ISO 9001 Standards and industry guidelines.
• Proven track record of performing and maintaining quality records that comply with regulatory requirements resulting in enhanced safety, profitability, productivity and quality.
• Experience in working with multi-site manufacturing facilities for pharmaceutical or medical device companies (start-up, mid-size and high-volume manufacturing).
• Proficient with ISO Standards (ISO 9001 – Quality Management Systems)
• Knowledgeable with USP 797 and USP 800
• Strong leadership, mentoring and interpersonal skills with the ability to interact with personnel at all levels and work independently.
• Strong organizational and project execution skills, with the ability to effectively manage multiple tasks, priorities and deadlines in a fast-paced environment.
• Must possess the personal characteristics or professionalism, commitment to excellence, customer service, detail orientation and accountability.
• Excellent verbal and written communication skills.

EOE Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

• This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned, and qualifications required may change.

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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

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