Director, Sterility Assurance

PCI Pharma Services; Bedford (NH); On-site; USD 180,000 - 260,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a Director of Sterility Assurance to lead the site’s aseptic manufacturing quality program, ensuring readiness for inspections and compliance with global regulations. The role requires 12+ years in a similar organization with at least five in management within aseptic production, and a strong background in regulatory guidance (CFR 210/211, 820, ICH Q8/9/10).

The director will drive CAPAs, EMPQ/APS processes, and QMS data management across functions.

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 including CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1) related to Aseptic Manufacturing and testing.
• 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.

Responsibilities

• Oversees the Aseptic Core Monitoring (ACM) program and ensures SMEs witness aseptic processes.
• Leads contamination control and aseptic practices with direct reports and QA teams.
• Manages EMPQ and APS processes and aligns local/customer requirements.
• Supports audits, deviations and CAPAs with risk assessments and data tools.
• Performs data trending and reporting for contamination control and environmental data, supports QMRs and Tier processes.
• Owns cleaning and disinfection programs and coordinates with EHS to reduce environmental impact.
• Ensures Sterility Assurance is on the shop floor and visible to operators and inspectors.

Skills

Leadership

Regulatory knowledge

Cross-functional leadership

Data analysis

Risk assessment

Aseptic/ GMP

Education

Bachelor degree in life sciences/engineering

Advanced degree desirable

Tools

eQMS

Process mapping tools

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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.

• 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.

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.

• 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

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.

• 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.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.