Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

   

Job Title:

VP Quality Business Segment Leader

Locations:

Choose a Location.

Business Type:

Other

Department/Function:

Quality

Reports to:

SVP Chief Quality and Compliance Officer

FLSA Status:

Exempt

Summary of Objective:

The VP Quality Segment Lead oversees and directs Quality and Regulatory activities at PCI within their responsible segment, as it aligns with the Quality SLT.  This includes providing leadership and guidance from a quality perspective and to assure the highest international.  To monitor and uphold strong GxP compliance levels across the PCI segments and facilities; ensuring we produce, package and store medicinal products that have all the expected attributes of quality, safety and efficacy.     

Function as a significant member of the management team and participate in not only the development of the local segment strategies but actively supports the global strategy.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

The individual works closely with the Segment OPS VP as their partner; with the primary goal to develop and execute the segment strategy which includes providing pristine customer service that delivers exceptional quality, and accelerated portfolio and revenue growth over time.        Actively support development and implementation of a quality vision which shapes the direction of the Quality organization and is a cohesive and a consistent standard globally.  Develop and execute quality strategies and systems to satisfy customer needs and complies with the applicable regulations of all countries in which PCI either manufactures or distributes products.In partnership with Segment OPS VP, Business Development (BD), GM’s and site Quality to understand forecast/pipeline information to support Client needs; Liaise with other key stakeholders to ensure sufficient resources are assigned to projects, escalate if needed.       Provide leadership and guidance for Segment Quality Management Teams as needed by supporting and assessing quality issues.Actively support development and implementation of a quality vision which shapes the direction of the Quality organization and is a cohesive and a consistent standard globally. Maintain awareness of projects, contacts, programs and operational/client issues, escalation and concerns. Periodic reporting to the Senior Leadership Team regarding metrics, initiatives and issues. Coordinate across Quality Segment Leaders to define, support and implement for Quality System Improvements. Periodically review and assess quality metrics to drive harmonization and improvements. Use critical thinking skills, logic and ingenuity to resolve issues and unique challenges while remaining within cGMP guidelines and PCI work practices and guidelines.                     Travel to PCI sites and customer sites, as appropriate.Establish a globally harmonized process and organizational infrastructure to support similar project initiatives between sites.Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.Performs other duties as assigned by Manager.Support regulatory and quality remediation activities, as needed for key customers and projects.Establish a working relationship with the Site Quality leads by supporting the team to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations.

Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Supervises 10-20 employees

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

Stationary Position: From 1/2 to 3/4 of the day. Move, Traverse: Up to 1/4 of the day.Operate, activate, use, prepare, inspect, or place: NoneInstall, place, adjust, apply, measure, use, or signal: None. Ascend/Descend or Work Atop: None.Position self (to) or Move (about or to): None.Communicate or exchange information: 3/4 of the day and up.Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth PerceptionAbility to focus ☒ No Special Vision Requirements         

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.

The noise level in the work environment is typically, moderate.

                                                                                                                                               

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

Bachelor's Degree in a related field and/or 10+ years related experience and/or training.College Level Mathematical SkillsIntermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.    Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

Ability to work independently and/or as part of a team.Ability to identify and resolve problems in a timely manner.Ability to hold oneself in a professional manner.Ability to display a willingness to make decisions. Expertise in DEA, FDA, EMEA, MHRA, HPRA, ANVISA and other regulatory agenciesExperience in management of multiple sites; with “big” pharma expereince        

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.