Executive Director, Quality

PCI Pharma Services•Bedford, NH

9d•Onsite

About The Position

The Executive Director, Quality provides strategic and operational leadership for Quality across the Development & Manufacturing Bedford campus, overseeing QA, QC, Validation, and the Quality Management System. This role is accountable for regulatory compliance, inspection readiness, patient safety, and Right-First-Time manufacturing while positioning Quality as a competitive advantage for PCI. As a key member of the Site Leadership Team and strategic partner to the Site GM, the Executive Director balances quality, safety, production, financial, supply, and customer priorities while building a high-performing Quality organization. The role also drives long-term Quality strategy, talent development, continuous improvement, regulatory readiness, and resource planning.

Requirements

Approximately 15+ years’ experience in a similar organization with at least five of those years in a senior management role, with the majority of this experience gained in an aseptic or sterile production environment.
Experience in Operations or Supply Chain, as well as core experience in Quality is a plus
Requires a solid 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). Ability to interpret other global regulations as necessary is required (e.g., WHO, ANVISA, etc).
Must have a demonstrable record of implementing and maintaining and total quality system, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. This person will assure that systems are in place and that inter- and intradepartmental communications are such that “things be done only once – the right way.”
Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards.
Strong knowledge base in production, aseptic operations, microbiology, analytical chemistry, and validation is required. It is acknowledged that background across these fields may be developed in many different forms.
Experience in facilitating Regulatory Agency inspections and communicating with global Regulatory Agencies.
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.
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.

Nice To Haves

Contract Manufacturing experience is a plus

Responsibilities

Develop, implement and communicate a clear strategic vision for Quality to be a Competitive Advantage throughout PCI.
Ensure QMS and other systems are functioning to maximize employee focus and enable Right-First-Time manufacturing.
Takes accountability for a constant state of inspection readiness, prioritizing regulatory compliance as a foundational requirement for stable patient supply. Ability to anticipate changes in the regulatory climate, and redesign processes accordingly.
As a senior leader on site and direct quality partner to the Site GM, understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. The SQH will develop a Quality Team capable of finding solutions that meet all must-have needs of all partners without ever compromising the safety of patients or the reputation of PCI.
Lead a team with overall responsibilities for QA, QC, & Validation across the D&M campus. This requires leadership in the day, to meet current needs. It also requires leadership for tomorrow to ensure development of personnel, succession planning, investment planning in systems and equipment, and continual pressure across the Site Leadership Team (SLT) to always have robustness and reliability at the forefront of all decisions.
The SQH is highly visible as a core member of the SLT. The SQH is aware that their behavior influences the behavior of everyone within Quality and on the site. The SQH models senior leadership behaviors.
Responsible for the quality aspects associated with manufacturing, testing, packaging, storage and release of clinical, commercial drug products and medical devices (as applicable) produced at the Development and Manufacturing facilities. Responsible for compliance to global standards of cGMP, as applicable.
Maintaining alignment with the SLT, the SQH translates Corporate and Segment requirements into Site Quality Strategic Planning and Quality yearly objectives, setting that meet compliance requirements and business needs.
Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.
Oversees compliance operations, responsible for complaint evaluation, internal and external investigations, internal and external supplier auditing, batch audit and disposition, and product data trending, etc.
Manages and coordinates all the regulatory inspections for Development and Manufacturing facilities. Acts as primary interface for communication with Regulatory Agency ﬁeld inspectors.
Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our clients, partners and suppliers.
Annually, develops Quality budget and then maintains budget throughout the fiscal year.