Director, Quality Control

Quality & Compliance Horsham, Pennsylvania


Description

The Director will hold a key leadership role within the Quality Control Department (consisting of chemistry and microbiology functions) providing analytical & microbiological support and guidance for all activities related to testing of drug substance, sterile diluent and drug product. Manage the OOS, investigations and corrective action system. Support and participate in regulatory inspections as required. Direct the development, management and improvement of quality systems and procedures as related to QC.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Quality Control Department

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Quality Control Operations

 

·         Manage and coordinate QC staff and/or consultants towards the timely completion of assigned duties and responsibilities.

·         Manage the planning, conduct, reporting and evaluation of the QC testing functions for cGMP commercial and development manufacturing, testing and distribution activities from Endo the manufacturing sites and contract filling facilities.

·         Direct the development, management and improvement of quality systems and procedures in QC to ensure compliance with all applicable laws, regulations and company quality standards in support of cGMP activities.

·         Oversee test method development, validation, transfer and troubleshooting.

·         Ensure adherence to Company safety procedures and guidelines.

·         Ensure development and training opportunities are offered to QC staff.

35%

Stability Program

·         Oversee routine release testing and stability activities for both development and commercial products as needed.

20%

Development & Launch

·         Participate in development and commercialization project teams and manage related GMP QC functions to assure timely completion of assigned activities.

·         Provide analytical testing support for Xiaflex® Clinical trials and market line extensions.

5%

Technical
Collaborations

·         Direct the QC contract testing relationships with external contractors and laboratories to assure complete and accurate exchange of information, resolution of issues, and timely completion of assigned activities.

·         Oversee method transfers from QC labs in Horsham to contract labs to support regulatory filings.

5%

Investigations

·         Oversee the QC compliance functions by managing support activities and providing resources for complaint investigations, training, and auditing activities where needed.

·         Ensure accurate completion of reported events in a compliant and timely manner.

·         Manage the OOS, investigations and corrective action system to assure compliance and timely and accurate completion of reported events.

10%

Regulatory Filings

·         Support regulatory affairs group and strategic business partners with the preparation of CMC filings, completing regulatory commitments and addressing questions from various regulatory agencies (e.g., FDA, EMA, SwissMedic, Health Canada, TGA and PMDA).

·         Prepare relevant information for annual product reviews.

20%

Readiness

·         Support and participate in regulatory inspections as required.

5%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  Minimum of a B.S. in Biology, Chemistry, Microbiology or equivalence in relevant experience. Graduate experience preferred.

§  12+ years of relevant experience in quality control laboratories within the pharmaceutical/biologics industry.

§  The ability to coordinate multiple priorities in a fast paced environment.

§  Supervisory or previous management experience required.


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Strong biologics and small molecule experience, especially facility inspection preparations and commercial operations.

§  Must have a demonstrated understanding and/or working knowledge of cGMP regulations ICH requirements, stability, analytical method development and validation.

§  Working knowledge in protein chemistry, standard analytical techniques and microbiology testing used in the biopharmaceutical industry.

§  In addition, demonstrated excellent interpersonal skills and flexibility, including demonstrated ability for successful leadership, influence and negotiation.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Excellent writing and strong verbal skills.

§  The ability to coordinate multiple priorities in a fast paced environment.

§  High degree of accuracy and attention to detail.

§  Strong communication skills with the ability to interact with all levels throughout the organization.

§  Solid organizational, analytical and problem solving skills.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  10% Travel

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.