Site Head, Quality – Biologics & Injectables | mid-sized Pharma | N. Carolina | RETAINED SEARCH

Cornerstone Search Group Published: January 20, 2017
Location
Category
Job Code
tfBH2555csg
Contact Email
tfascia@cornerstonesg.com

Description

Site Head, Quality – Biologics & Injectables | mid-sized Pharma | N. Carolina | RETAINED SEARCH

Cornerstone Search Group has been retained by a fast-growing and stable mid-sized global pharmaceutical company for a Site Head, Quality (GMP) leadership position.  Responsibility will include complete Quality oversight and leadership for a multi-dosage form manufacturing campus, with new manufacturing lines and/or buildings being built to focus on sterile injectables and biologics. You will have the opportunity to grow and build the Quality function as the company has continued growth plans across a rich internal NBE and NCE pipeline as well as a rapidly growing Generics and Complex Generics business.

ATTRACTIVE FEATURES ABOUT THIS OPPORTUNITY:

  • High Visibility and High Impact: This is a leadership role for a company that has a strong focus on Quality. You will be only two steps removed from the CEO and play an active leadership role at a critical point in their growth and at a high-profile manufacturing campus site that is being built out.
  • Company Culture: We have helped this Company hire a number of people in executive and senior leadership positions and we know firsthand from them that they enjoy this company’s focus on fast, common-sense decision-making as well as the focus on quality.
  • Company Stability & Growth: This Company generates significant annual revenues and profits and has been growing quickly and steadily for many years.
  • Strong Leadership: Proven executive leadership that is highly engaged, emotionally even-keeled, entrepreneurial, and committed to creating an environment where top-notch people can get the job done right.

SUMMARY OF RESPONSIBILITIES:

  • Site leadership and oversight across the Quality Assurance and Quality Control function at a multi-dosage form manufacturing site that is growing with new lines and buildings.
  • Ensure GMP compliance in line with the FDA as well as other global regulatory body standards.
  • Manage a growing team of direct reports (hiring, training, etc.).
  • Design, implement and lead quality strategies, procedures and systems.
  • Financial leadership across planning, allocation and management of approved budget.
  • Management of systems and resources for validation, ensuring that Quality Systems governed by the operating procedures are monitored and audited regularly and are in a state of compliance as per cGMP and current regulatory requirements.
  • Site maintenance and oversight, remaining in constant compliance and audit readiness by ensuring implementation of Quality Systems as per cGMP and meeting all governmental and regulatory compliance requirements.
  • Ensure adherence to SOPs relating to stability programs and confirm that any stability failures have been reported as appropriate to site and headquarters management and the respective regulatory agency.
  • Devise, review, implement and manage systems within the group to achieve continuous process improvement.
  • Ensure the performance of GMP audits by an external source to provide additional auditing controls and suggestions for improvements based on current industry standard.

 LOCATION: North Carolina

RELOCATION ASSISTANCE: Yes

DESIRED SKILLS & EXPERIENCES:

  • 10-15 years of Quality leadership experience including either sterile injectables or biologics.
  • Direct report/people management experience.
  • Strong emotional intelligence, integrity, humility, perseverance, a sense of urgency, and the motivation/desire to make an impact for a fast-growing company.
  • Experience with starting up a new manufacturing site or manufacturing lines is a plus.
  • Experience in a generics environment is a plus.

CONTACT:

Tom Fascia | Partner

tfascia@cornerstonesg.com

973.656.0220 x717

https://www.linkedin.com/in/thomasfascia

Corey Ackerman | Sr. Partner

cackerman@cornerstonesg.com

973.656.0220 x716

https://www.linkedin.com/in/coreyackerman

CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054 USA

www.cornerstonesg.com

USA: 973.656.0220

CH: 41 61 508 7010

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