Role: US Operations Leader
Pay: $120,000 to $150,000 with bonus.
Location: Raleigh-Durham (North Carolina) - primary location; Southern California –
additional location; travel among sites required (>50%)
Department: Operations
Key Competencies: Research material handling / scientific aptitude
Regulated / controlled environments knowledge (FDA, CAP, GxP, ISO, ICH)
Data information flow (ie. LIMs familiarity, CRM usage, ERP data relationships)
Leading people in multiple locations / Global organization
Process improvement methodology / Business acumen
Relationships: Finance
Commercial
Quality Assurance
IT
HR
Customers
Suppliers
Summary:
As leader of US Operations, the candidate will be responsible for oversight of all operations personnel (site managers / operational staff), the day to day operations of locations (currently, Research Triangle Park (RTP) and San Diego facilities) including implementing a fully integrated operational model with other locations (within and outside of the US). The candidate will also collaboratively support organic growth as well as acquisitive growth (has the experience to manage rapid expansion among existing sites and/or additional sites) through intimate participation in integration efforts.
The candidate will work collaboratively with a global team and will manage the US teams directly to deliver best-in-class services to the company’s customer base of global life science in biological, compound and device research.
While Astoriom is an established company, the candidate should expect to build upon and create foundational operational functions. Having good familiarity with IT systems such as sample storage / lab information management (LIMS) systems and the quality control processes associated with
sample management, will ensure uniformity of operations across Astoriom’s US facilities and compliance with the company’s exacting global quality standards.
The candidate will be responsible for managing service delivery and provider relationships including shared services on same site (ie. the relationship with Astoriom’s co-tenants in the Research Triangle Park facility) while ensuring a seamless handover of samples and related information between the companies.
Problem-solving, proactive and forward-thinking are skills necessary to identify opportunities to improve the customer experience and to make company-wide processes more efficient while driving a culture of continuous improvement.
Responsibilities:
Key responsibilities include:
- Leading and managing the operational teams (including site managers) in Astoriom’s US facilities, maintaining efficient and safe operation of the sites at all times;
- Working with site managers and Quality team to ensure that all local licenses and standards are adhered to, including:
o ISO 9001 Quality System requirements, EU (Directive 2003/94/EC) and USA (21 CFR Part 210/211) current GxP relevant requirements (ie. Good Manufacturing Practice regulations), CAP regulations and HTA regulations .
o 21 CFR Part 11 regulations - FDA guidelines for electronic records and electronic signatures
o ICH Topic Q1A (R2) - Stability Testing of New Drug Substances and Products
o ICH Topic Q1B (R2) - Photostability Testing of New Active Substances and Medicinal Products
- Liaising with clients and staff to make certain clients receive complete and accurate information concerning practical operation of the sites;
- Combining knowledge of client operations and needs and liaising with Astoriom’s commercial team in order to identify opportunities to grow share of wallet with the company’s customers;
- Liaising with Astoriom’s co-tenants (ie. North Carolina facility) to deliver smooth running of day-to-day operations, provide a seamless customer experience and protect / grow revenue flow;
- Ensuring information held in key Astoriom operating systems (lab information management system, service engineer scheduling, and electronic quality management system) is accurate;
- Ensuring that business continuity plans are in place for possible interruptions.
- Providing complete, accurate and timely management information including reporting capacity levels and issues in a timely and accurate fashion to relevant stakeholders;
- Ensuring consistency of operational processes with other Astoriom sites;
- Working with the Finance team to ensure all work is accurately documented and invoiced;
- Co-ordinating with relevant staff and/or service providers to ensure effective validation and servicing of onsite equipment as necessary;
- Ensuring FDA, CAP, ICH and GMP regulations are applied and adhered to at all times;
- Reporting of all out of Specification incidents, deviations and Customer Complaints to the Quality Assurance Officer in accordance with SOPs;
- Ensuring peripheral equipment (e.g. data loggers, auto fills, etc) is operational at all times, reporting of equipment breakdowns in a timely fashion. Maintaining critical spares in accordance with site requirements;
- Overseeing third-party suppliers such as internet and site maintenance providers;
- Participating in the Annual personnel performance evaluation process, in accordance with Company Policy;
- Performing any other duties as may be reasonably required commensurate with grade and experience.
- Attending any training endeavors as appropriate to role or as reasonably requested
Capabilities:
5+ years of experience in a senior operations role in a life science sample storage (biorepository, stability storage) environment, with prior experience with stability storage strongly preferred.
Familiarity with sample management / lab information management systems, temperature monitoring software, and electronic quality management software.
Ability to engage with prospective and existing customers at a senior operational level to supporting the sales team in securing new business.
Excellent interpersonal and people management skills.
Prior experience in managing multiple sites, and ability to travel to sites as required.
Strong quality background with working knowledge of CAP, 21 CFR Part 11, ICH and FDA regulations and guidelines
Experience with integration of acquired companies preferred
Job Type: Full-time
Pay: $120,000.00 - $150,000.00 per year
Benefits:
- 401(k) matching
- Health insurance
- Paid time off
Shift:
- Morning shift
Work Location: In person
