Operations Leader
Operations Leader
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USD 120000 - 150000
1 Vacancy
Job Description
Travel: up to 50%
Must live in either Raleigh-Durham NC or San Diego CA
$120k-$150k Bonus
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 Astorioms locations (currently Research Triangle Park (RTP) and San Diego facilities) including implementing a fully integrated operational model with other Astoriom 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 companys 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 Astorioms US facilities and compliance with the companys exacting global quality standards.
The candidate will be responsible for managing service delivery and provider relationships including shared services on same site (i.e. the relationship with Astorioms 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.
Key responsibilities include:
- Leading and managing the operational teams (including site managers) in Astorioms 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:
- 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 .
- 21 CFR Part 11 regulations - FDA guidelines for electronic records and electronic signatures
- ICH Topic Q1A (R2) - Stability Testing of New Drug Substances and Products
- 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 Astorioms commercial team in order to identify opportunities to grow share of wallet with the companys customers;
- Liaising with Astorioms 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 guideline
- Experience with integration of acquired companies preferred
Employment Type
Full-Time
