Director of Pharmaceutical Quality Systems
14 hours ago
The Director of Pharmaceutical Quality Systems will lead the Quality Systems, Validation, Compliance, and Supplier Quality Teams in ensuring the implementation of a phased appropriate program. This individual will be a quality expert for compliance and compliance-related activities at the site.
Main Responsibilities- Manage 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.
- Lead Quality Systems and Compliance; own strategy to support business requirements.
- Drive GMP system and process continuous improvement initiatives.
- Responsible for training of Quality Systems and Compliance team members. Ensure a robust and effective site training program.
- Maintain policies, standards, and procedures for the Quality Systems and Compliance functions.
- Oversee development of metrics and Management Review.
- 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.
- Leads GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.
- Anticipates and resolves problems effectively.
- 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.
- Provides guidance in the subject of aseptic technique/operations, clean room procedures/processes, environmental monitoring programs, and aseptic process simulation studies.
- Ability to perform in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals.
- Supports other GXP assignments as required.
- 8+ years of team management experience.
- Master of Science (M.Sc.) or PhD with 10+ years of experience; or
- Bachelor of Science (B.Sc.) with 13+ years of experience; or
- Associate Degree with 16+ years of experience.
- Advanced communication skills.
- Self-starter (advanced skill).
- Advanced problem-solving skills.
- Advanced critical/logical thinking/analysis skills.
- Advanced risk management skills.
- Advanced project management skills.
- Advanced time management skills.
- Advanced conflict resolution skills.
- Advanced teamwork and collaboration skills.
- Advanced negotiation skills.
- Advanced innovative thinking skills.
- Advanced decision-making skills.
- Advanced people management/development skills.
- Advanced strategic leadership skills.
- Customer service-oriented.
- Goal/results-oriented.
- Detail-oriented.
- Mastery knowledge of cGMP.
- Mastery knowledge of aseptic techniques.
- Mastery knowledge of biopharmaceutical operations.
- Mastery knowledge of quality systems.
- Working knowledge of computer applications.
- Mastery knowledge of GXP enterprise systems.
- Mastery knowledge of regulations and compliance.
- Masterly knowledge of creating and approving technical documentation.
- Advanced knowledge of process and method qualification.
- Working knowledge of process and method qualification.
- Mastery knowledge of managing process introduction tasks.
- Masterly knowledge of building new business processes/strategies for improvement and implementation.
- Mastery knowledge of demonstrating the feasibility/ROI of business processes/strategies for improvement.
Work is generally performed in a manufacturing and office environment, with some laboratory and warehouse environment work.
Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.
Salary and Benefits$180,000 to $240,000, depending on experience.
Medical, Dental, and Vision.
Life Insurance.
401k.
Paid Time Off.
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