Director Pharmaceutical Quality Systems Job In USA

Overview:

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large. The Director, Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.

External US:

Summary of Position:

The Director, Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance and Supplier Quality Teams ensuring implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance related activities at the site. The individual will also support cross functional teams for supplier selection, inspection readiness, due diligence activities, and quality system processes.

Major Activities & Responsibilities:

1. Manages the Quality Systems and Compliance functions including Deviation, CAPA, Change Control, Risk Management, Training, Document Management, Validation (equipment and CSV), Supplier Quality (material suppliers and service providers), Regulatory and Management programs.
2. Lead Quality Systems and Compliance; own strategy to support business requirements.
3. Drive GMP system and process continuous improvement initiatives.
4. Responsible for training of Quality Systems and Compliance team members. Ensure a robust and effective site training program.
5. Maintain policies, standards and procedures for the Quality Systems and Compliance functions.
6. Oversee development of metrics and Management Review.
7. Act as Quality management contact with the FDA, EMA, and other regulatory authorities worldwide, as well as partners regarding quality issues including field alerts, recalls, or regulatory actions.
8. Leads GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
9. Anticipates and resolves problems effectively.
10. Expert in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
11. Provides guidance in the subject of aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and aseptic process simulation studies.
12. Ability to perform in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
13. Supports other GXP assignments as required.

Education / Experience:

1. 8+ years of team management experience
2. Master of Science (M.Sc.) or PhD with 10+ years of experience; or
3. Bachelor of Science (B.Sc.) with 13+ years of experience; or
4. Associate Degree with 16+ years of experience

Behavioral Competencies:

1. Advanced communication skills
2. Self-starter (advanced skill)
3. Advanced problem solving skills
4. Advanced critical / logical thinking / analysis skills
5. Advanced risk management skills
6. Advanced project management skills
7. Advanced time management skills
8. Advanced conflict resolution skills
9. Advanced teamwork and collaboration skills
10. Advanced negotiation skills
11. Advanced innovative thinking skills
12. Advanced decision making skills
13. Advanced people management/ development skills
14. Advanced strategic leadership skills
15. Customer service-oriented
16. Goal/results oriented
17. Detail oriented

Technical Competencies:

1. Mastery knowledge of cGMP
2. Mastery knowledge of aseptic techniques
3. Mastery knowledge of biopharmaceutical operations
4. Mastery knowledge of quality systems
5. Working knowledge of computer applications
6. Mastery knowledge of GXP enterprise systems
7. Mastery knowledge of regulations and compliance
8. Masterly knowledge of creating and approving technical documentation
9. Advanced knowledge of process and method qualification
10. Working knowledge of process and method qualification
11. Mastery knowledge of managing process introduction tasks
12. Masterly knowledge of building new business processes/strategies for improvement and implementation
13. Mastery knowledge of demonstrating the feasibility/ROI of business processes/strategies for improvement

Work Environment:

Work is generally performed in a manufacturing and office environment, with some laboratory and warehouse environment work.

Physical Requirements:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.

Salary and Benefits:

1. $180,000 to $240,000, depending on experience
2. Medical, Dental and Vision
3. Life Insurance
4. 401k
5. Paid Time Off

Equal Opportunity Employer:

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

Agency Notice:

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.