Quality Director, Regulatory Compliance & Quality Systems

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Quality Director, Regulatory Compliance & Quality Systems

Location : CA-Los Angeles, US

CA-Los Angeles, US

Contract Type : Regular Full-Time

Area : Quality

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

This position is responsible for overseeing and leading an organization and infrastructure to ensure sustained business excellence through reinforcing compliance with applicable worldwide standards and requirements.

This position is responsible for overseeing the compliance management program,

risk management activities, technical training, and corrective and preventive action system. This position directs GB quality system audits and coordinates compliance / training / audit efforts with the other Grifols manufacturing sites for consistency.

This position has overall responsibility for establishing and maintaining compliance performance metrics and management information systems at the GB site and directly reporting current compliance status to top management for Grifols Biological Product sites.

This position oversees and directs assessment, intervention, and follow-up activities that will ensure integration of compliance into the business to result in on-going consistent conformance to all applicable worldwide regulations.

This position is responsible for identifying risks and directing action to eliminate and / or mitigate potential regulatory liability for Biological Products.

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

• Direct and oversee the analysis of regulatory inspections, internal audits, customer audits, vendor audits and change notifications.
• Direct examinations and assessments as to the effectiveness of defined Quality Systems and determine the level of conformance to all worldwide regulations and standards.
• Oversee and provide direction and guidance for responses to all regulatory agency inspection observations. Intervene and oversee follow-up actions for high-risk situations to ensure permanent and complete resolution.
• Lead and direct technical expertise and support service as needed in the investigation of significant and / or chronic compliance problems.

Initiate investigations and subsequent corrective actions whenever global quality system performance does not meet requirements.

Maintain management awareness of the quality and regulatory compliance status of the organization through routine reporting and performance measurement.

Lead and / or participate in established Quality forums such as GB Quality Management Review Meetings, that highlight quality trends and bring forth strategic and / or product decisions.

• Direct development and maintenance of an effective quality system, including oversight of Quality Compliance Policies.
• Establishes quality metrics and develops collection, analysis and reporting systems to promote timely detection, communication and corrective action.
• Oversee and determine the compliance requirements for the technical training program at GB.
• Provide quality oversight for various quality systems. This oversight can include quality review, quality risk management, change controls, validations, environmental monitoring, commodities, finished products, and corrective / preventative actions.

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’s degree in Biology, Chemistry, or related science field is required
• A minimum of 10 years Quality Assurance / Control, Quality Systems, Quality Management, or Regulatory Management experience in the pharmaceutical / biotech or medical device industry.

An advanced degree in science related field or management and / or prior experience in multi-facility management are desirable.

• Incumbent must have in-depth knowledge of applicable GMPs, regulations, and standards - both domestic and international.
• Must have a proven track record in policy development and implementation.
• The incumbent must have demonstrated the ability to stay current with emerging regulatory inspection trends and maintaining compliance confidence in past areas of responsibility.
• Incumbent must possess excellent problem solving skills and communication skills (i.e., verbal, written, and electronic).
• In addition, the incumbent must have demonstrated ability to successfully interface with all levels of management and customers or suppliers in various functional modalities to assure a consistent supply of quality good and services.
• The incumbent must also have demonstrated highly developed skills in leadership, negotiation, and influence in order to successfully interface with individuals from scientific, production, regulatory and executive management backgrounds to achieve Grifols quality and business goals and objectives.
• Staying current with regulatory inspection trends and initiatives.

The estimated pay scale for the Quality Director, Regulatory Compliance & Quality Systems role based in Los Angeles, CA, is $k-$k / per year.

Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, 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!

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, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

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