Site Operations Lead

Catalent

San Diego,CA  

2019-11-16 2019-12-16
administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position Overview:



Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here











The Site Operations Lead provides oversight and leadership to the Operations team members at the Clinical Supply Services site in San Diego, California. This role is accountable for the safety, quality, delivery, cost (SQDC) process within Clinical Supply Operations, overseeing the functions of pre-production, packaging, materials management, pre-distribution, and distribution. SQDC includes overall ownership of safety events and improvements, quality investigations and corrective actions, on-time start and delivery, and budget of the operation. The CSS San Diego facility is a growing facility with an organizational structure that is flexible across the Operations/Project Management functions. The successful candidate should possess a "hands-on" approach, be willing to embrace the Catalent values and business ethos and lead the team successfully whilst continually improving in line with the leadership requirements.







This position reports to the Vice President, CSS Operations.



This position dotted line reports to the General Manager, ODD San Diego. A strong collaboration with ODD Site Management is required.











Leadership





+ Patient First mentality – everything we do could impact the health of our patients.



+ Provides technical and operational guidance to employees, colleagues, and customers.



+ Provides process guidance to site subject matter experts (SMEs).



+ Strong partnership and collaboration with business stakeholders. Defines and manages expectations.



+ Able to assess and develop strategies for achieving the needs of the CSS Site.



+ Seeks information about and identifies opportunities to support and enhance critical business functions and processes. Makes recommendations linked to the CSS Network’s strategy.



+ Adheres to company policies and procedures.



+ Establish metrics regarding Operational SQDC, in order to track and trend completion as well as root cause and identify areas for quality and efficiency improvement – review these KPIs on a periodic basis and assign actions. Produce the metrics for submission to corporate for regular review.



+ Has direct leadership responsibilities for Operations team:







+ Maintain timely and clear communications with employees; ensure that information regarding new organizational initiatives, programs and policies is disseminated



+ Monitor workloads of direct reports and adjust staff and workload appropriately



+ Monitor and effectively utilize overtime where appropriate



+ Perform employee performance cycle for employees directly managed



+ Develop talent to improve employee productivity and ensure staffing levels are sufficient to achieve corporate and local objectives



+ Recommend courses of action on human resources matters, including salary administration, transfers, hiring, terminations, professional development, performance reviews, position description preparation and employee counselling







+ Holds self and team accountable for Safety, Quality, Delivery, and Cost as outlined below:





Safety





+ Accountable for a safe working environment.



+ Proactively identifies safety concerns that may affect a site, individuals or other colleagues.



+ Leads root cause analysis of injuries and safety events at the Site.



+ Facilitates immediate correction to the process where required to prevent recurrence of injuries and safety events.





Quality





+ Adheres to the Quality Management System.



+ Accountable for timely completion of Quality events for the Operations team.



+ Accountable for timely completion of Training actions for the Operations team.



+ Performs client and regulatory audits and tours.



+ Supports the Site Quality Management team in all aspects of Regulatory, Policy, and SOP requirements.





Delivery





+ Manages the Production schedule.



+ Accountable for the On Time Receipt of inbound delivers, the On Time Packaging of batch records, and the On Time Delivery of shipments to depots, clinics, and other locations.



+ Local System Owner (or deputy) for CSS IT Systems (Clinicopia, GSA, SupplyFLEX, etc).





Cost





+ Responsible for the control of costs against budget/forecast.



+ Supports the Site Finance team in all aspects of budget and forecast.



+ Establish relationships with external service providers to perform additional work as required in a cost-effective manner.



+ Responsible for effective use of overtime for any hourly employees.













Additional Responsibilities:





+ Maintains a current training record



+ Maintains expenses reports on a timely basis in line with corporate policy









Communication Responsibilities:





+ Engages appropriate individuals across the sites for understanding of responsibilities and actions.



+ Customer service mind-set.



+ Manages escalations of deliverables impacting project timelines and customer requirements.













Experience:



GMP experience within a Clinical Trial Supply environment



At least five years of relevant industry experience is required, focusing on the pre-production (bill of materials, batch records, work orders) and/or production aspects of packaging (encapsulation, bottling, blistering, labelling, kit assembly)







HS Diploma or equivalent required, BS or equivalent preferred









+ Have a strong knowledge of Standard Operating Procedures (SOPs), and current Good Manufacturing Processes (cGMPs) and their purpose



+ Have a strong knowledge of CSS IT Systems



+ Possesses a full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.)



+ Demonstrated ability to plan and independently manage multiple functions



+ Possess the ability to work under tight and emergent deadlines



+ Excellent written, verbal and interpersonal communication skills, including the ability to present information



+ Blend knowledge and analysis with logic, active listening and a continuing interest in simplification



+ Act ethically and use empathy



+ Demonstrate a bias toward action. Get things done. Be willing to take a position and assert influence to drive improvement. Foster teamwork to get results









Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.







personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.











Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.







Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





Catalent = Catalyst + Talent







Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!







personal initiative. dynamic pace. meaningful work.







Catalent is the perfect place to grow your career if…





+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).











+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!











+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.











+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.











+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!











+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.











Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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