Director, Sterility Assurance

Essential Duties and Responsibilities

• Manages the Aseptic Core Monitoring (ACM) program, which ensures highly technical aseptic SMEs are witness to all aseptic processes in the production areas.
• Develops technical acumen and decision-making skills in direct reports and the wider Quality team, specifically related to contamination control and aseptic practices.
• Oversees the execution of PCI’s standard EMPQ and APS processes and ensures any local or customer-driven requirements are included.
• Supports audits, deviations and CAPAs with risk assessments and other well-developed tools or data.
• Performs trending and reporting for all contamination control and environmental data. Discusses data with area owners and helps build action plans where required. Provides data or systems that allow for the retrieval of data for QMRs and the Tier process.
• Owns the cleaning and disinfection programs for the site. Works closely with industry experts to ensure Cleaning and Disinfection is effective and efficient. Aligns with EHS to drive down environmental impact from this activity.
• Knows that Sterility Assurance happens on the production floor and demonstrates a commitment to being on the floor, in production, with Operators and raising awareness of the importance of our quality culture.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Accountable for a team that provides 24/7 coverage and should prioritize connecting with all shifts on a routine basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture.

Qualifications

• Requires a minimum of a bachelor degree, with preference for those in life sciences, engineering or other science disciplines. An advanced degree is desirable.
• Approximately 12+ years’ experience in a similar organization with at least five of those years in a management role, with the vast majority of this experience gained in an aseptic or sterile production environment.
• Contract Manufacturing experience is a plus
• A formal background in Industrial Microbiology and Contamination Control is desired
• Requires an advanced knowledge of global regulatory guidance in including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1) related to Aseptic Manufacturing and testing. Ability to interpret other global regulations as necessary is required (e.g., WHO, ANVISA, etc).
• Hands-on experience with QMS data management software (eQMS), process mapping tools, risk assessments, data analysis, and software for presentation of all of these is required. The ability to communicate the compliance status as well as measure it is paramount to success in this role.
• Cross-functional leadership and influence is necessary for success, with this role leading process risk assessments, program improvements, and other activities that require input from multiple stakeholders with multiple priorities, all of which must be met sufficiently.
• The Director of Sterility Assurance will ensure the site is always inspection-ready on the shop floor. The Director will serve as the key SME for Agency discussions, but will develop their team continuously to present PCI’s compliant state on the floor or in the conference room.