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Catalent · 1 day ago

Director, Quality Control Analytical

Harmans, MD

Full-time

Onsite

Director/Executive

$188K/yr - $259K/yr

10+ years exp

Catalent is a leading provider of GMP development and manufacturing services for biopharmaceuticals. The Director of QC Analytical is responsible for overseeing Quality Control strategies and operations, ensuring compliance with GMP and company specifications while driving continuous improvement in the laboratory.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Accountable for all activities within the QC Analytical department

Leads the team on the strategies for daily activities of QC Analytical and QC Support Services and assures that job activity deadlines are met on a timely basis

Hires and oversees the training of QC department personnel

Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly

Interacts and communicates with customers to assure expectations are established, agreed to, and achieved

Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer

Identify, maintain, and report functional KPIs to site management

Assures execution of testing programs to assess the quality of raw materials, components, in-process and finished goods, and effectiveness of production processes

Works with leaders to generate new/revise Standard Operating Procedures for analytical test procedures

Other duties as assigned

Qualification

Analytical testingGMP environmentAuditingComplianceRegulatory guidanceLeadership experienceMulti-taskingCommunication skillsProblem-solving skillsAttention to detail

Required

Bachelor's degree required and 10+ years of relevant experience with 8+ years of direct management experience

Experience in Analytical testing required

Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance's (US and EU)

Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business)

Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels

Creative individual with excellent problem solving and trouble shooting skills and ability to work effectively under pressure to meet deadlines

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Preferred

Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred

Benefits

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

Dynamic, fast-paced work environment.

Community engagement and green initiatives

Generous 401K match and Paid Time Off accrual

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)