Overview:

This position is responsible for providing supervision to the Quality Assurance On-the-Floor (OTF) team, supporting sterile and oral solid dose manufacturing operations.  This position provides direct oversight for day-to-day quality and compliance of operations.  This position develops and implements tactical initiatives directed by Senior Management. This position provides direct support and guidance for quality event investigation and resolution and is responsible for escalation of quality events to appropriate leadership within and outside of quality, as appropriate.

Responsibilities:

• Ensures the Quality OTF team provides adequate and appropriate support to ensure the safety, identity, strength, purity and quality of the products manufactured and that operations are compliant with all Standard Operating Procedures, Specifications, and current Good Manufacturing Practice, and applicable Regulations
• Has authority to approve or reject written standards, including Master Production Records, Standard Operating Procedures, Work Instructions, Specifications, Sampling Instructions, etc.
• Responsible for review and approval of risk assessments, change controls, investigations, corrective/preventive actions, and complaint records.
• Participates as appropriate in management processes for quality and compliance.
• Participates as needed in third party inspections and completion of applicable commitments.
• Monitors site metrics pertaining to their area to ensure adequate performance of quality systems and supports management review.
• Supports data and documentation review as needed for Annual Product Reviews.
• Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need.
• Supports the Internal Audit Program
• Supports recall process where required
• Responsible for supporting and partnering with Documentation Control
• Responsible for the supervision of direct reports.

Qualifications:

Skills/Abilities:

• Required Moderate to Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
• Required experience with quality systems for drug product development, manufacturing and quality control operations.
• Required Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Required strong written and oral communication, organizational, and prioritization skills.
• Preferred experience in participating in pharmaceutical technology transfer teams.
• Preferred experience in the qualification of facilities, utilities, equipment and processes.
• Preferred experience with six sigma and operational excellence initiatives
• Preferred Moderate knowledge of the regulatory process from drug development through commercial manufacturing.

Preferred Personal Attributes:

• Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker, innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
• Good communication skills at all levels of the organization
• Excellent technical writing skills
• Strategic planning
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction, influence cross-functional partners and development of others

Education and Experience:

• Requires a Bachelor’s degree in a scientific discipline or equivalent.
• For QA Supervisor: 6+ years of experience in a Quality Assurance role in the pharmaceutical industry, experience with parenteral dosage forms or equivalent strongly desired. Oral Solid Dose and/or Combination Product related experience desired.; 3+ years of supervisory/team lead experience preferred
• Proficient in Microsoft Office
• Knowledge of SAP, LIMS, TrackWise preferred

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