Director, Compliance

Essential Duties and Responsibilities

• Manages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs and the Annual Product Quality Review (APQR) program.
• Develops technical acumen and decision-making skills in direct reports.
• Oversees PCI Pharma's risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders.
• Leads complex audit, deviation and CAPA investigations.
• In collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality.
• Manages quality event trend reports and metrics to measure key quality attributes.
• Accountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations.
• Develops and maintains relevant quality sections of contractual agreements with clients.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• 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.

Work Environment & Physical Demands

• Constantly required to sit, and to reach to use computers and other office equipment.
• Constantly stand for extended periods of time, up to four (4) hours/time.
• Required to gown into cleanrooms or into aseptic spaces on a regular basis.
• Frequently required to lift up to 20 pounds.
• Constantly required to view objects at close and distant ranges with hand and eye coordination.
• Frequently required to communicate with others.

Qualifications

• Requires a minimum of a bachelor's degree, with preference for those in life sciences, chemistry, engineering or other science disciplines. An advanced degree is desirable.
• Approximately 10+ years' experience in a similar organization with at least five of those years in a management role, with the majority of this experience gained in an aseptic or sterile production environment. Contract Manufacturing experience is a plus.
• Industry experience outside of Quality, as well as core experience in Quality is a plus.
• Requires an advanced knowledge of global regulatory guidance including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1) related to Quality Systems and 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.
• The Director of Compliance will ensure the site is always prepared logistically for a Regulatory Inspection, recruiting, training and drilling personnel from throughout the site to fill all positions required in a regulatory inspection. The Director will generally serve as the host of the lead inspector.