Sr. Director, Quality

About the role

The Sr. Director, Quality is responsible for overseeing all quality functions at the Hobart manufacturing sites, including cGMP compliance and product quality.

Responsibilities

• Manages all aspects of plant Quality Systems including CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint investigation and validation functions.
• Supports an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
• Ensures the evaluation of batch records and that all necessary testing is carried out.
• Approves specifications, sampling instructions, test methods and other QC procedures.
• Ensures the authorization of all controlled documents, including records retention.
• Ensures the monitoring and control of the manufacturing and Quality Control environments.
• Ensures compliance with cGMP standards.
• Ensures the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance both for Corporate and for applicable regulatory agencies.
• Coaches and develops the team to High Performance while fostering a culture of team ownership.
• Ensures team compliance with all policies, procedures and site/company regulations.
• Manages each team member’s performance management.
• Exhibits accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
• Provides leadership for employee relations through effective communications, coaching, training and development and eliminates roadblocks in order for the team to move forward.
• Supplies the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Leads and/or supports investigations. Author, approve and/review area quality and safety exceptions and investigation reports.
• Ensures on-time completion of all corrective action items assigned to area.
• Identifies opportunities to reduce costs, reduce risk and improve service.

Requirements

• Bachelor's degree in chemistry, microbiology or similar life sciences or technical field such as engineering, mathematics, etc.
• Minimum of 15 years of pharmaceutical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of solid dosage form drug products and bulk drug substances.
• Minimum 10 years managerial experience in a pharmaceutical quality/regulatory affairs environment.

Preferred Skills/Qualifications

• Previous experience serving as a pharmaceutical manufacturing site leader of a significant quality function (Total Plant population >500 persons, Quality Function >75 persons).
• Exceptional oral and written communication skills.
• Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports.
• Knowledge of FDA and International regulations and guidances in the area of Quality Systems for pharmaceutical products.
• Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host.
• Strong patient and customer focus.

Skills/Competencies

• Strong writing skills to effectively communicate technical/clinical information to others.
• Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
• Superior verbal communication skills including impeccable telephone etiquette.
• Scientific literature searching and evaluation skills.

Organizational Relationships/Scope

This position reports to the Executive Director, Quality. This position will have several direct reports which include the leaders of the Hobart Site Quality Management. This position will have frequent communication and working relationships with USA manufacturing plant management and QA/RA personnel as well as all senior leaders of the organization.

Contact with regulatory authorities

This position will have frequent communication and working relationships with regulatory authorities, state, federal and international.

Working Conditions

• This Position works primarily in an office environment.
• Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required.
• Will require occasional periods in the manufacturing areas and walking throughout the plants.
• Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm.
• PPE is required to be worn approximately 10 to 15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off-site business meetings and professional training seminars and conferences.

Pay

The expected base pay range for this position is $200,000 – $230,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.

Disclaimer

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.