Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- As the functional quality leader for multiple business units, the QO Director understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. With the Asset Leadership Team, the QO Asset Lead visible and solves issues relevant to our employees in the area, and coaches the shop floor teams to work collaboratively and with solutions in mind.
- Controls and monitors the execution of PCI’s QMS and other systems to ensure they are functioning effectively and in such a way as to maximize employee focus and enable Right-First-Time manufacturing. Provides consistent feedback to QMS system owners on how to improve performance.
- Maintains systems that provide a clear line-of-sight to batch disposition requirements, tracking discrete steps that lead to final disposition including, but not limited to those owned in the Asset (batch record review, deviation management) and those provided by partners (QC data, EM results).
- Deliver predictable quality outcomes through continuous improvement, process controls, monitoring of operational activity, and consistent communication and decision-making. Administers (schedules, assigns, monitors and trends) the shop floor GEMBAs and process observations to empower area Ops leaders to make informed choices on priority and criticality of initiatives.
- Manages a team of Quality professionals across multiple shifts, driving for compliance and consistency in routine operation and in response to upset conditions (events or deviations). Fosters community across the front-line quality personnel on site and in the network to share experiences and best practices to continuously trend toward more aligned decisions.
- Empowers their team to make the right call on the shop floor, but also always provides systems for review and sharing to ensure decisions made are the best possible. Leads the team as a coach as much as possible, while never risking patient safety.
- Quality Operations has the full understanding of production operations, decisions, and issues and as such, are the customer-facing Quality organization. The QO Asset Lead is the primary contact for customer communications, supported in escalations by the SDQO when necessary.
- The incumbent is the local visible leader, setting the example of PCI’s Industrial Quality Mindset. They do not only focus on the most current “emergency” only. They invest time developing staff and ensuring a strong process knowledge and succession planning in the Asset area.
- Ensures budgets are developed accurately and are met.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties the employee is:
- 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: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Approximately 5+ years’ experience in pharmaceutical / GMP manufacturing.
- Aseptic processing experience is highly preferred
- Past experience as a supervisor or manager of employees is beneficial
- Contract Manufacturing experience is a plus
- Experience working in a regulated industry is highly preferred, with 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) prioritized.
- Experienced industrial management skills are required for continued success in the role. The QO Asset Lead will be responsible for meeting budget, weekly and daily staffing, ensuring training / competency is available and that time is available to remain current with training, and monitoring workload per shift and over the course of the days and weeks.
- Communication, transparency, and solution-finding in a networked organization are foundational to the role. Interactions with shop floor personnel (Operations, Maintenance, and various Quality partners) as well as next-level leadership should be expected every day.
- A working knowledge of 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 and continued growth will be supported within this role.
- Requires a minimum of a bachelor degree or equivalent relevant experience or certifications, with preference for those in life sciences, chemistry, engineering or other science disciplines.
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