Site Quality Head

Quality Seymour, Indiana


Description

The Site Quality Head will be located in our Seymour Indiana facility with Lannett's wholly owned subsidiary, Kremers Urban Pharmaceuticals.

The Site Quality Head will provide overall strategic and tactical leadership for the Quality unit and personnel. The Quality unit consists of Quality Assurance and Quality Control related functions. This position is responsible ensuring cGMP compliance by establishing and overseeing policies, procedures, and systems for the entire product life cycle. The incumbent must collaborate with Operations leadership to establish and execute procedures and processes that support efficient and customer oriented manufacturing.  The position ensures that all facilities, equipment, and operations are cGMP compliant.

He or she will ensure overall regulatory compliance and will interact with customers, auditors and regulatory agencies. He or she will be responsible for the development of qualified staff to ensure effective testing, execution of roles and responsibilities and attainment of operational and development goals. This position is located in Seymour, Indiana.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

Interface with development, regulatory affairs, finance, sales, IT, HR and operation organizations.

The responsibility to disposition finished goods, raw materials, packaging components and labeling.

Responsible for maintaining Quality Systems (Document Control, Change Control, Investigations, CAPA)

Responsible for the development of a site quality plan that supports the corporate quality plan.

Reviews and provides final approval of validation documents (protocol, summary reports, etc.) and technical reports, manufacturing and laboratory investigation reports, change controls, SOP’s and other controlled documents.

Actively participate in meetings where Quality input is needed and encourage interdepartmental communication.

Develop short and long term goals.

Establish, communicate and sustain metrics to monitor performance and compliance

Develop pro-active quality systems that support quality right first time

Act as an SME on corporate initiatives

Support agency inspections.

Oversee and communicate Quality resources.

Revise and update standard operating procedures as needed

Overall management and coordination of QA/QC activities

Timely, effective support to Operations

Perform other related duties as required.

 

 

 

SUPERVISORY RESPONSIBILITIES 

QA & QC
 

QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

A firm knowledge of cGMPs.

Strong written and oral communication skills.

Proficient with data management systems.

Experience investigating laboratory OOS and manufacturing deviations

Excellent problem solving skills

Strong leadership and organizational skills

 

 

EDUCATION and/or EXPERIENCE

 

BS degree in Sciences, Engineering, Business is required

Minimum of 10-15 years of experience in quality with at least 5 in pharmaceuticals required

Minimum 5-7 years in a supervisory or lead role.

 

MBA or equivalent preferred.